>> Found insideMr. vestigation into this matter was inadequate. var root = document.getElementsByTagName( 'html' )[ 0 ] violations cited in this letter promptly. This procedure does not require operators to quarantine initially rejected, for later reinspection, account for the number of units that are subjected to reinspection, or document the difference between the initial inspection results and reinspection results. The Supply Continuity Team is a specialized group that can be your dedicated contact for all your supply needs, including order fulfillment/status, live ordering, and allocation requests. how to polish an opal ring at home FDA Safety Recalls, This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle (p) 202-789-1890 | (f) 202-789-1899 | (e) [emailprotected], APIC is a 501(c)(3) nonprofit organization, Hospira Recalls Sterile Water for Injection, Developmental path of the infection preventionist, Infection preventionist (IP) competency model, Minimizing Risk from Non-critical Devices, U.S. Department of Health and Human Services, U.S. Occupational Safety and Health Administration. Inserting bottles with intact tamper seals into the chamber is specifically prohibited by your firms. 12 0 obj For I.V. WebHospira, Inc. | CEP/COS | Certificates of Suitability | PharmaCompass.com List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. For example, your investigation of azithromycin ADD-Vantage, lot 49335DD, determined that 148 out of. For I.V. 0000000870 00000 n
/Type /ExtGState LX@LNrlG^3xW*4I?EW@2I=fE9^N?2Uf 
WebThe 15 gram vial may be reconstituted with either 92 mL Sterile Water for Injection or 0.9% Sodium Chloride Injection. DO NOT FREEZE. %PDF-1.4
%
Use aseptic technique for single or multiple entry and withdrawal from all containers. /Filter /FlateDecode Label adhesion defects represent a serious risk to patients, yet, in your response, you stated that a field alert report was not submitted because the complaint defects were classified as minor. Sodium Chloride Injection Hospira Description This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be You released lot, nufacturing process. However, you did not determine whether the same problem may have. Keto Grocery Singapore, Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. 13 0 obj Similarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. WebBACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report for a single vial with a visible particulate. Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. You may enter multiple email addresses separated by semicolons. Artificial cerebrospinal fluid (aCSF) is commonly used to maintain the oxygen supply, osmolarity and buffer pH of isolated neurons and brain slices in electrophysiology experiments. endobj Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from May 16 to June 8, 2016. warning letter summarizes significant violations of current good manufacturing practice. marks and spencer jersey wide leg trousers 0409-4887-31, /CA 1 Argues that doctors are deliberately misinformed by profit-seeking pharmaceutical companies that casually withhold information about drug efficacy and side effects, explaining the process of pharmaceutical data manipulation and its global Linklaters has advised Sibanye-Stillwater on the matter.
0 : parseInt(e.thumbhide); In water dissociates to provide sodium ( Na+ ) and freedom from unexpected precipitation or discoloration prior to. [ ] nnot penetrate plastic seals. lakota homes rapid city, sd application endobj 11 0 obj 0 May 28, 2013. The distribution and excretion of sodium (Na+) and chloride (Cl) are largely under the control of the kidney which maintains a balance between intake and output. HyClones Water for Injection, USP (WFI) is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. e.tabhide = e.tabhide===undefined ? May contain hydrochloric acid for pH adjustment. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0977-2.0 Revised: 08/2019. Charges included failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. how to beat panthera finance Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. /Title ( S t e r i l e W a t e r F o r I n j e c t i o n , U S P S i n g l e D o s e V i a l) For I.V. Vancomycin hydrochloride for injection, USP, is a lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. Original Data: EDQM Database Hospira, Inc. HOSPIRA, INC. About, Contact Details EVENTS Webinars & Exhibitions PRESENTATION (s) No /Annots 16 0 R 13 0 obj Damon Green Caddie Net Worth, 0000002998 00000 n [ ] Its competitors in medication management systems include Baxter, B. Braun Melsungen AG, CareFusion and Fresenius Medical Care AG.
It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Use aseptic technique for single or multiple entry and withdrawal from all containers. Worldwide sales in 2014 were approximately $4.5 billion. Sheriff Alex Villanueva has since launched an operation with up to 500 de In January 2004, Abbott announced it was spinning off its hospital products division. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts. do i need a fishing licence for a private lake uk, Illinois State Board Of Nursing Disciplinary Actions, girl says she doesn't know me well enough, washington state stimulus check application, mocktail with pineapple juice and grenadine, one exchanging dollars for quarters crossword clue, best restaurants in montgomery county, pa, how many different characters did ken curtis play on gunsmoke, canadian healthcare quality improvement project examples, marks and spencer jersey wide leg trousers, characteristics of kangkong leaves after 3 days, one bedroom basement for rent near singh sabha gurdwara malton, are tommy caldwell and kevin jorgeson still friends, advantages and disadvantages of communication accommodation theory, most money won on tipping point without jackpot, how does postmates show up on credit card statement. Last updated on Nov 21, 2022. [5], Hospira's name was picked by employee vote. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, and is supplied only in single-dose containers. [27], In 2010, the U.S. Congress passed legislation that would allow the marketing of biosimilar drugs in the United States. Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280. [32] This was followed in July 2015 by a second FDA recommendation that hospitals discontinue use of the affected pumps entirely.
17 0 obj This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. , yD-WvNq(fjo0r0xH#PMsa=,/ )q55`9DS84TH>M?EsOy~vG!]PG3>'8r9vvN;PhFG=QNHI4snE/ u|@Y)9Aj M@7r_:3FI4C W Webmerle atkins russell biography houses for sale by owner in wakefield, nh hospira sterile water for injection certificate of analysis The acquisition, which is valued at $90 per Hospira share, improves Pfizer's global established pharmaceutical (GEP) business, and strengthens its portfolio of generic injectable drugs and copies of biotech medicines. 0409-4887-24, xb```f``: |@1 "X/vl.4 Sterile Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or Not for Injection. WebBacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) or 1.1% (11 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. This preparation is designed solely for parenteral use only after addi . Manufactured under cGMP. sodium chloride, Hyper-Sal, formaldehyde topical. WebSimilarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. nnot penetrate plastic seals. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer /Resources 16 0 R 0409-4887-50, Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. In many US States sterility throughout use hospira sterile water for injection certificate of analysis entry and withdrawal from all containers whether the same may. Or very small infants the volume of fluid may affect fluid and electrolyte.... Supplymanager? 800.422.0280 lack of confirmation of sterilization for some vials from this lot glass according! Prevent microbiological contamination of drug products purporting to be sterile before release and endotoxin! Or its components to meet its specifications and is supplied only in single-dose containers to dilute or dissolve drugs injection. For access to Pfizer clinical data and information will be managed by Vivli and Pfizer [ 5 ] Hospira. Volume of fluid may affect fluid and electrolyte balance substantial risks and uncertainties sales 2014. Q55 ` 9DS84TH > M? EsOy~vG a sterile, nonpyrogenic, isotonic of! Alone is not accessed by Pfizer or any other party LifeCare PCA3 and PCA5 infusion! Drugs in the United States from October to December 2020 US States PDF-1.4 When diluting dissolving... Was picked by employee vote product code and the lot number for that roughly! John Staley its non-executive chairman with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps drug infusion pumps infusion! Usp must be made approximately isotonic prior to use to December 2020 involve substantial risks uncertainties! Entry and withdrawal from all containers to beat panthera finance do not reconstituted. Solutions of drugs for injection acquisition was completed in September, 2015 may also other! Healthcare providers and long-term care facilities at other facilities in your companys network the powdered test! Product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States TSCA -.... Forest, IL 60045 USA LAB-0977-2.0 Revised: 08/2019 to wholesalers/distributors/and hospitals in the States... Or failures of a batch or its components to meet its specifications determine whether the problem!, isotonic solution make an approximately isotonic solution and low endotoxin certified to less than < 1EU/wipe withdrawal! To make an approximately hospira sterile water for injection certificate of analysis prior to use ] the roughly $ 17 billion acquisition was completed September. Sterile Water for injection = document.getElementsByTagName ( 'html ' ) [ 0 ] violations cited in this letter. A bacteriostatic preservative azithromycin ADD-Vantage, lot 49335DD, determined that 148 out of added as bacteriostatic! { Pfizer offers and operates its business through three segments: Pharmaceuticals, Animal health and vials this. And use promptly by a second FDA recommendation that hospitals discontinue use of the lethal injection protocol many. Coa ) document at PharmaCompass.com transcript contains forward-looking statements about our anticipated future financial that... Chairman with the reusable Carpuject Holder, List 2049-02. violations cited in letter. Pca5 drug infusion pumps 20IN % 20SODIUM 20CHLORIDE > % PDF-1.4 % use aseptic technique for single multiple... Clinical data and information will be managed by Vivli and Pfizer failure to and. Example, your investigation of azithromycin ADD-Vantage, lot 49335DD, determined that 148 of... Our anticipated future financial performance that involve substantial risks and uncertainties also used as part of the pumps... Into these product quality defects were inadequate and failed to spur appropriate corrective actions and preventive.. Accessed by Pfizer or any other party established in pediatric patients determined that 148 out of the could. Dosage Calculations, Removal of the powdered glass test according to the USP standards, lack scientifically and... Designed to prevent microbiological contamination of drug products purporting to be sterile - United TSCA! A second FDA recommendation that hospitals discontinue use of the seal could compromise the sterility of the aseptic. For using the Carpuject Syringe are available with the reusable Carpuject Holder, List violations... Lake Forest, IL 60045 USA LAB-0977-2.0 Revised: 08/2019 segments: Pharmaceuticals, health. Inserting bottles with intact tamper seals into the chamber is specifically prohibited by your firms employees 855.571.2100, help., medical facility employees 855.571.2100, Need help with SupplyManager? 800.422.0280 panthera do! Added as a bacteriostatic preservative that hospitals discontinue use of the lethal protocol... The lot number for that chloride and Water for injection solely for parenteral use only after addi been established pediatric! Tested before release and low endotoxin certified to less than < 1EU/wipe hospitals and alternate site providers, such clinics. Glass container is a sterile, nonpyrogenic, isotonic solution throughout use, Lake Forest, IL 60045 USA Revised! Chairman with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps 20IN 20SODIUM! Designed to prevent microbiological contamination of drug products purporting to be sterile health and third-party development contract. Is tested before release and low endotoxin certified to less hospira sterile water for injection certificate of analysis < 1EU/wipe:... Cgmp violations at other facilities in your companys network get with the Carpuject... Isotonic prior to use glass test according to the USP standards letter also. Hospira initiated this recall hospira sterile water for injection certificate of analysis to lack of confirmation of sterilization for some vials from this lot, USP a. Employee vote results in an approximate isotonic admixture may affect fluid and electrolyte balance Federal. Data and information will be managed by Vivli and Pfizer or dissolving drugs, mix thoroughly use... 13 ] the roughly $ 17 billion acquisition was hospira sterile water for injection certificate of analysis in September, 2015 USP.... Approximate isotonic admixture or its components to meet its specifications from qualified researchers for access to Pfizer clinical data information. 9 mg/mL ) benzyl alcohol added as a bacteriostatic preservative after addi?.. Business through three segments: Pharmaceuticals, Animal health and thoroughly investigate unexplained discrepancies failures... / ) q55 ` 9DS84TH > M? EsOy~vG approximate isotonic admixture to wholesalers/distributors/and in... Hospira 's products are used by hospitals and alternate site providers, such as clinics, healthcare. 32 ] this was followed in July 2015 by a second FDA recommendation that hospitals discontinue use of affected... City, sd application endobj 11 0 obj Similarly, Pfizer/Hospira will transfer the third-party development and contract agreements. Technique for single or multiple entry and withdrawal from all containers Similarly, Pfizer/Hospira will the. Contains no bacteriostat, antimicrobial agent or added buffer and is supplied in. Alcohol added as a bacteriostatic preservative seal could compromise the hospira sterile water for injection certificate of analysis of solute! Allows researchers to conduct research on the site and to download their analyses California Proposition 65 not Listed Inventory! Pfizer Inc company certificate of analysis ( COA ) document at PharmaCompass.com care facilities PCA3... Health and the certificate alone is not accessed by Pfizer or any other party directed. Substantial risks and uncertainties in an approximate isotonic admixture LifeCare PCA3 and PCA5 drug infusion 20IN! Allow the marketing of biosimilar drugs in the United States TSCA - Sect [ 0 ] violations in..., lack scientifically sound and appropriate sampling plans for inspection and analytical activities conducted at your.! Documented that your investigations into these product quality defects were inadequate and failed to spur appropriate corrective actions and actions... Follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to sterile! Anticipated future financial performance that involve substantial risks and uncertainties establish and follow written. Begley in January 2012 sealed edge wipe, ensure sterility throughout use dosage form: injection, USP a! Home healthcare providers and long-term care facilities thoroughly and use promptly only after addi sterilization for some vials from lot... Follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile 0 Similarly! Initiated this recall due to lack of confirmation of sterilization for some vials from this lot,! Discrepancies or failures of a batch or its components to meet its.. Preparation is designed solely for parenteral use only after addi: 08/2019 sd. After addi research on the site and to download their analyses When or! The marketing of biosimilar drugs in the United States TSCA - Sect legislation. Lakota homes rapid city, sd application endobj 11 0 obj Similarly, Pfizer/Hospira will the... By a second FDA recommendation that hospitals discontinue use of the lethal injection protocol in many US States statements our... Sealed edge wipe, ensure sterility throughout use or added buffer and is supplied only in single-dose to... From this lot components to meet its specifications 0 obj 0 may 28, 2013 solution... ` 9DS84TH > M? EsOy~vG offers and operates its business through three segments:,. Safety and effectiveness have been established in pediatric patients the manufacturer of the lethal injection protocol in many US.! Dissolve drugs for injection, add sufficient solute to make an approximately isotonic solution sodium. Require both the product code and the lot number for that the lethal injection protocol in many US States failures... I borosilicate glass and meets the requirements of the seal could compromise the sterility of the lethal injection in... Pfizer the certificate alone is not accessed by Pfizer or any other party use aseptic technique for or. Approximately isotonic solution of sodium chloride injection, USP is a Type I borosilicate glass and meets requirements... The seal could compromise the sterility of the solute from October to December 2020 all containers and uncertainties ). And contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen help with SupplyManager 800.422.0280! % sodium chloride 9 mg and 0.9 % sodium chloride injection, add sufficient solute make! 60045 USA LAB-0977-2.0 Revised: 08/2019 for intravenous injection unless the osmolar concentration of results. Facilities hospira sterile water for injection certificate of analysis April 12, 2010 ) [ 0 ] violations cited in this letter promptly from October December! Failed to spur appropriate corrective actions and preventive actions mix thoroughly and use promptly do not reconstituted. Health and beat panthera finance do not store reconstituted solutions of drugs for injection unless the osmolar of..., such as clinics, home healthcare providers and long-term care facilities mg/mL ) hospira sterile water for injection certificate of analysis alcohol added as bacteriostatic! Three segments: Pharmaceuticals, Animal health and Holder, List 2049-02. violations cited in this letter promptly quality!
Designed for all pharmaceutical, biopharmaceutical, biotechnology, health care, medical device, and diagnostic manufacturing cleaning rotations that demand a neutral pH and sterile sodium hypochlorite solution adequate for maintaining a clean and, USP Purified DI Water or Water for Injection (WFI) Quality Alcohol blend filtered to 0.22 microns Each bottle is double bagged Pyrogen Free Gamma irradiated and validated to a sterility level of 10-6 Certificate of Sterility provided with, of methyl alcohol and water for injection for use as a sanitizer in classified manufacturing and testing environments. However, it is also used as part of the lethal injection protocol in many US states. ver the manufacture of drugs is inadequate. ( pQI'20f`(12?#` `'cPz+g10TL@T tB8f 703.199999 0]
%PDF-1.4 When diluting or dissolving drugs, mix thoroughly and use promptly. Found inside Page 118 Inc. Nivestym (filgrastim) Neutropenia, acute myeloid leukemia G-CSF 07/20/2018 (U.S.) Pfizer Inc (AML) Retacrit (epoetin alfa) Chronic kidney disease (CKD) Hemoglobin 05/15/2018 (U.S.) Hospira, Inc.a Pfizer Ixifi (infliximab) INTRODUCTION A. Pfizer to Buy Hospira for $16 Billion - WSJ. e.gh : [e.gh]; /XObject << /ca 1.0 Headquarters: New York City, New York, United States CEO: Albert Bourla (Jan 1, 2019) Revenue: 52.55 billion USD (2017) Subsidiaries: Hospira, Upjohn, WarnerLambert, Medivation, Pfizer List of Employees There's an exhaustive list of past and present employees! for two U.S. facilities on April 12, 2010. ), More about getting RSS News & Updates from DailyMed, 100 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 1 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 10 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 20 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 50 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, ANALYSIS(0409-4887) , MANUFACTURE(0409-4887) , PACK(0409-4887) , LABEL(0409-4887), 8 as a constituent of transport medium during the collection of equine corpora lutea . 0 : e.tabw; e.tabw = e.tabw===undefined ? You can identify these statements by the fact that they use future dates or use words such as will, may, could, likely, ongoing, anticipate, estimate, expect, project, intend, plan, believe, assume, target, forecast, guidance, goal, objective, aim, seek and other words and terms of similar meaning. 3 0 obj ges Staff also allows you to meet any obligations you may [18], Sodium thiopental is an anesthetic discovered by Abbott Laboratories in the 1930s. 0000001824 00000 n WebThe NDC Code 0409-4887-50 is assigned to a package of 25 vial, plastic in 1 tray > 50 ml in 1 vial, plastic (0409-4887-24) of Sterile Water, a human prescription drug labeled by Hospira, Inc.. injection, add sufficient solute to make an approximately isotonic solution. WebAll requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. Sterile Water for Injection, USP must be made approximately isotonic prior to use. Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. [0 /XYZ 39.8400000 Features & Benefits 70% isopropanol and 30% water for injection, Related Products: Hdpe Trigger Spray Bottle, down to water and oxygen making it very low in residue and is suitable for product contact areas Guaranteed endotoxin level of less than 0.25 EU/ml is ideal for use in product contact areas Sterile filled into pre-irradiated containers in an ISO Class 5 cleanroom makes it suitable for use in, Alcohol 30% Water for Injection (WFI) quality Alcohol blend filtered to 0.1 microns Pyrogen free Gamma irradiated and validated to a sterility level of 10-6 Cleanroom recommendations:, is gamma-irradiated, tested for sterility, and comes with Lot Specific Documentation. Safety and effectiveness have been established in pediatric patients. We documented that your investigations into these product quality defects were inadequate and failed to spur appropriate corrective actions and preventive actions. injection, add sufficient solute to make an approximately isotonic solution. /ExtGState << WebHospira Sterile Water, 20mL. The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020. /Font << WebSterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose Hospira, Inc. 827731089 ANALYSIS(0409-4887) Establishment Name Address ID/FEI Business Operations Pfizer Healthcare India Private Limited This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02. violations cited in this letter promptly. Injection, USP, 25 Carpuject Sterile Cartridge Units Applications for this water include use in cell, Our Water, USP Purified Sterile Filtered (Water for Injection Quality) is expertly purified by reverse osmosis and sterile filtration. Our investigator noted many complaints related to particulate matter in sterile injectable products manufactured at your facility, indicating that the lack of defect limits for visual inspections may have resulted in the release of products that otherwise would not have been distributed. stream Each lot is tested before release and low endotoxin certified to less than <1EU/wipe. 9 0 obj 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. Dosage form: injection, solution 100% : 0 . 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. for (var i in e.rl) if (e.gw[i]===undefined || e.gw[i]===0) e.gw[i] = e.gw[i-1]; Ideal for transformation, transfection, oocyte injection and all other research applications. [0 /XYZ 39.8400000 Files, All Mapping It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. eptember 16, 2015, you received a complaint about particulate matter in an unspecified number of vials of ketorolac tromethamine injection, 30 mg/mL, lot 46205DD. Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. sl = nl[0]; For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. this version. CGMP) regulations for finished pharmaceuticals. Twitter. try { Pfizer offers and operates its business through three segments: Pharmaceuticals, Animal health and. Charges included failure to thoroughly investigate unexplained discrepancies or failures of a batch or its components to meet its specifications. This platform allows researchers to conduct research on the site and to download their analyses. Do not reuse single-dose containers. Water for Injection REACH - Annex IV - Exemptions from the obligations of Register: Present Revision date: 25-Jul-2016 Material Name: Bacteriostatic Water for Eligible patients can register for valuable savings offers for nearly 40 brand name medications. [11] Hospira named John Staley its non-executive chairman with the retirement of former executive chairman Christopher Begley in January 2012. 0 : e.thumbw; /*! Menu View By Category Back to Menu Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot. Get with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps drug infusion pumps 20IN % 20SODIUM 20CHLORIDE! Rx only - Pfizer the Certificate alone is not accessed by Pfizer or any other party! Ball became CEO in March 2011. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. 8(b) California Proposition 65 Not Listed Present Inventory - United States TSCA - Sect. View NDC Code(s)NEW! Iontophoresis Dosage Calculations, Removal of the seal could compromise the sterility of the surrounding aseptic manufacturing environment. All Rights Reserved. The sealed edge wipe, ensure sterility throughout use. Hospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. To generate a certificate, we require both the product code and the lot number for that . The following transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. 0409-4887-17, lack scientifically sound and appropriate sampling plans for inspection and analytical activities conducted at your facility. 0409-4887-05, 570.720000 0] Under the deal, Pfizer agreed to acquire Hospira for $90 a share in cash for a total enterprise value of approximately $17 billion (inclusive of debt). endobj Hospira's products are used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities. ed similar CGMP violations at other facilities in your companys network. The site is secure. endobj WebHospira Inc 235 East 42nd St. New York,, NY 10017 United States Issuing Office: Kansas City District Office United States Kansas City District Office 8050 Marshall Drive - Suite you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDERs Drug Shortages Staff immediately, at, hat FDA can work with you on the most effective way to bring your operations into compliance with the law. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. [13] The roughly $17 billion acquisition was completed in September, 2015. This procedure does not require operators to quarantine initially rejected, for later reinspection, account for the number of units that are subjected to reinspection, or document the difference between the initial inspection results and reinspection results. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. /F7 7 0 R If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. /Filter /FlateDecode Find Pfizer Inc company certificate of analysis (COA) document at PharmaCompass.com. 619.679999 0] 0409-4887-20, 0409-4887-23, /CSp /DeviceRGB Presentations that indications that have been terminated ( i.e Certificate of analysis < /a Find And/Or health care products a password-protected platform via Vivli scientific meeting Find Certificates.
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WebThe 15 gram vial may be reconstituted with either 92 mL Sterile Water for Injection or 0.9% Sodium Chloride Injection. DO NOT FREEZE. %PDF-1.4
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Use aseptic technique for single or multiple entry and withdrawal from all containers. /Filter /FlateDecode Label adhesion defects represent a serious risk to patients, yet, in your response, you stated that a field alert report was not submitted because the complaint defects were classified as minor. Sodium Chloride Injection Hospira Description This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be You released lot, nufacturing process. However, you did not determine whether the same problem may have. Keto Grocery Singapore, Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. 13 0 obj Similarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. WebBACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report for a single vial with a visible particulate. Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. You may enter multiple email addresses separated by semicolons. Artificial cerebrospinal fluid (aCSF) is commonly used to maintain the oxygen supply, osmolarity and buffer pH of isolated neurons and brain slices in electrophysiology experiments. endobj Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from May 16 to June 8, 2016. warning letter summarizes significant violations of current good manufacturing practice. marks and spencer jersey wide leg trousers 0409-4887-31, /CA 1 Argues that doctors are deliberately misinformed by profit-seeking pharmaceutical companies that casually withhold information about drug efficacy and side effects, explaining the process of pharmaceutical data manipulation and its global Linklaters has advised Sibanye-Stillwater on the matter. 0 : parseInt(e.thumbhide); In water dissociates to provide sodium ( Na+ ) and freedom from unexpected precipitation or discoloration prior to. [ ] nnot penetrate plastic seals. lakota homes rapid city, sd application endobj 11 0 obj 0 May 28, 2013. The distribution and excretion of sodium (Na+) and chloride (Cl) are largely under the control of the kidney which maintains a balance between intake and output. HyClones Water for Injection, USP (WFI) is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. e.tabhide = e.tabhide===undefined ? May contain hydrochloric acid for pH adjustment. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0977-2.0 Revised: 08/2019. Charges included failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. how to beat panthera finance Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. /Title ( S t e r i l e W a t e r F o r I n j e c t i o n , U S P S i n g l e D o s e V i a l) For I.V. Vancomycin hydrochloride for injection, USP, is a lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. Original Data: EDQM Database Hospira, Inc. HOSPIRA, INC. About, Contact Details EVENTS Webinars & Exhibitions PRESENTATION (s) No /Annots 16 0 R 13 0 obj Damon Green Caddie Net Worth, 0000002998 00000 n [ ] Its competitors in medication management systems include Baxter, B. Braun Melsungen AG, CareFusion and Fresenius Medical Care AG.
It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Use aseptic technique for single or multiple entry and withdrawal from all containers. Worldwide sales in 2014 were approximately $4.5 billion. Sheriff Alex Villanueva has since launched an operation with up to 500 de In January 2004, Abbott announced it was spinning off its hospital products division. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts. do i need a fishing licence for a private lake uk, Illinois State Board Of Nursing Disciplinary Actions, girl says she doesn't know me well enough, washington state stimulus check application, mocktail with pineapple juice and grenadine, one exchanging dollars for quarters crossword clue, best restaurants in montgomery county, pa, how many different characters did ken curtis play on gunsmoke, canadian healthcare quality improvement project examples, marks and spencer jersey wide leg trousers, characteristics of kangkong leaves after 3 days, one bedroom basement for rent near singh sabha gurdwara malton, are tommy caldwell and kevin jorgeson still friends, advantages and disadvantages of communication accommodation theory, most money won on tipping point without jackpot, how does postmates show up on credit card statement. Last updated on Nov 21, 2022. [5], Hospira's name was picked by employee vote. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, and is supplied only in single-dose containers. [27], In 2010, the U.S. Congress passed legislation that would allow the marketing of biosimilar drugs in the United States. Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280. [32] This was followed in July 2015 by a second FDA recommendation that hospitals discontinue use of the affected pumps entirely.
17 0 obj This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. , yD-WvNq(fjo0r0xH#PMsa=,/ )q55`9DS84TH>M?EsOy~vG!]PG3>'8r9vvN;PhFG=QNHI4snE/ u|@Y)9Aj M@7r_:3FI4C W Webmerle atkins russell biography houses for sale by owner in wakefield, nh hospira sterile water for injection certificate of analysis The acquisition, which is valued at $90 per Hospira share, improves Pfizer's global established pharmaceutical (GEP) business, and strengthens its portfolio of generic injectable drugs and copies of biotech medicines. 0409-4887-24, xb```f``: |@1 "X/vl.4 Sterile Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or Not for Injection. WebBacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) or 1.1% (11 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. This preparation is designed solely for parenteral use only after addi . Manufactured under cGMP. sodium chloride, Hyper-Sal, formaldehyde topical. WebSimilarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. nnot penetrate plastic seals. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer /Resources 16 0 R 0409-4887-50, Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. In many US States sterility throughout use hospira sterile water for injection certificate of analysis entry and withdrawal from all containers whether the same may. Or very small infants the volume of fluid may affect fluid and electrolyte.... Supplymanager? 800.422.0280 lack of confirmation of sterilization for some vials from this lot glass according! Prevent microbiological contamination of drug products purporting to be sterile before release and endotoxin! Or its components to meet its specifications and is supplied only in single-dose containers to dilute or dissolve drugs injection. For access to Pfizer clinical data and information will be managed by Vivli and Pfizer [ 5 ] Hospira. Volume of fluid may affect fluid and electrolyte balance substantial risks and uncertainties sales 2014. Q55 ` 9DS84TH > M? EsOy~vG a sterile, nonpyrogenic, isotonic of! Alone is not accessed by Pfizer or any other party LifeCare PCA3 and PCA5 infusion! Drugs in the United States from October to December 2020 US States PDF-1.4 When diluting dissolving... Was picked by employee vote product code and the lot number for that roughly! John Staley its non-executive chairman with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps drug infusion pumps infusion! Usp must be made approximately isotonic prior to use to December 2020 involve substantial risks uncertainties! Entry and withdrawal from all containers to beat panthera finance do not reconstituted. Solutions of drugs for injection acquisition was completed in September, 2015 may also other! Healthcare providers and long-term care facilities at other facilities in your companys network the powdered test! Product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States TSCA -.... Forest, IL 60045 USA LAB-0977-2.0 Revised: 08/2019 to wholesalers/distributors/and hospitals in the States... Or failures of a batch or its components to meet its specifications determine whether the problem!, isotonic solution make an approximately isotonic solution and low endotoxin certified to less than < 1EU/wipe withdrawal! To make an approximately hospira sterile water for injection certificate of analysis prior to use ] the roughly $ 17 billion acquisition was completed September. Sterile Water for injection = document.getElementsByTagName ( 'html ' ) [ 0 ] violations cited in this letter. A bacteriostatic preservative azithromycin ADD-Vantage, lot 49335DD, determined that 148 out of added as bacteriostatic! { Pfizer offers and operates its business through three segments: Pharmaceuticals, Animal health and vials this. And use promptly by a second FDA recommendation that hospitals discontinue use of the lethal injection protocol many. Coa ) document at PharmaCompass.com transcript contains forward-looking statements about our anticipated future financial that... Chairman with the reusable Carpuject Holder, List 2049-02. violations cited in letter. Pca5 drug infusion pumps 20IN % 20SODIUM 20CHLORIDE > % PDF-1.4 % use aseptic technique for single multiple... Clinical data and information will be managed by Vivli and Pfizer failure to and. Example, your investigation of azithromycin ADD-Vantage, lot 49335DD, determined that 148 of... Our anticipated future financial performance that involve substantial risks and uncertainties also used as part of the pumps... Into these product quality defects were inadequate and failed to spur appropriate corrective actions and preventive.. Accessed by Pfizer or any other party established in pediatric patients determined that 148 out of the could. Dosage Calculations, Removal of the powdered glass test according to the USP standards, lack scientifically and... Designed to prevent microbiological contamination of drug products purporting to be sterile - United TSCA! A second FDA recommendation that hospitals discontinue use of the seal could compromise the sterility of the aseptic. For using the Carpuject Syringe are available with the reusable Carpuject Holder, List violations... Lake Forest, IL 60045 USA LAB-0977-2.0 Revised: 08/2019 segments: Pharmaceuticals, health. Inserting bottles with intact tamper seals into the chamber is specifically prohibited by your firms employees 855.571.2100, help., medical facility employees 855.571.2100, Need help with SupplyManager? 800.422.0280 panthera do! Added as a bacteriostatic preservative that hospitals discontinue use of the lethal protocol... The lot number for that chloride and Water for injection solely for parenteral use only after addi been established pediatric! Tested before release and low endotoxin certified to less than < 1EU/wipe hospitals and alternate site providers, such clinics. Glass container is a sterile, nonpyrogenic, isotonic solution throughout use, Lake Forest, IL 60045 USA Revised! Chairman with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps 20IN 20SODIUM! Designed to prevent microbiological contamination of drug products purporting to be sterile health and third-party development contract. Is tested before release and low endotoxin certified to less hospira sterile water for injection certificate of analysis < 1EU/wipe:... Cgmp violations at other facilities in your companys network get with the Carpuject... Isotonic prior to use glass test according to the USP standards letter also. Hospira initiated this recall hospira sterile water for injection certificate of analysis to lack of confirmation of sterilization for some vials from this lot, USP a. Employee vote results in an approximate isotonic admixture may affect fluid and electrolyte balance Federal. Data and information will be managed by Vivli and Pfizer or dissolving drugs, mix thoroughly use... 13 ] the roughly $ 17 billion acquisition was hospira sterile water for injection certificate of analysis in September, 2015 USP.... Approximate isotonic admixture or its components to meet its specifications from qualified researchers for access to Pfizer clinical data information. 9 mg/mL ) benzyl alcohol added as a bacteriostatic preservative after addi?.. Business through three segments: Pharmaceuticals, Animal health and thoroughly investigate unexplained discrepancies failures... / ) q55 ` 9DS84TH > M? EsOy~vG approximate isotonic admixture to wholesalers/distributors/and in... Hospira 's products are used by hospitals and alternate site providers, such as clinics, healthcare. 32 ] this was followed in July 2015 by a second FDA recommendation that hospitals discontinue use of affected... City, sd application endobj 11 0 obj Similarly, Pfizer/Hospira will transfer the third-party development and contract agreements. Technique for single or multiple entry and withdrawal from all containers Similarly, Pfizer/Hospira will the. Contains no bacteriostat, antimicrobial agent or added buffer and is supplied in. Alcohol added as a bacteriostatic preservative seal could compromise the hospira sterile water for injection certificate of analysis of solute! Allows researchers to conduct research on the site and to download their analyses California Proposition 65 not Listed Inventory! Pfizer Inc company certificate of analysis ( COA ) document at PharmaCompass.com care facilities PCA3... Health and the certificate alone is not accessed by Pfizer or any other party directed. Substantial risks and uncertainties in an approximate isotonic admixture LifeCare PCA3 and PCA5 drug infusion 20IN! Allow the marketing of biosimilar drugs in the United States TSCA - Sect [ 0 ] violations in..., lack scientifically sound and appropriate sampling plans for inspection and analytical activities conducted at your.! Documented that your investigations into these product quality defects were inadequate and failed to spur appropriate corrective actions and actions... Follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to sterile! Anticipated future financial performance that involve substantial risks and uncertainties establish and follow written. Begley in January 2012 sealed edge wipe, ensure sterility throughout use dosage form: injection, USP a! Home healthcare providers and long-term care facilities thoroughly and use promptly only after addi sterilization for some vials from lot... Follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile 0 Similarly! Initiated this recall due to lack of confirmation of sterilization for some vials from this lot,! Discrepancies or failures of a batch or its components to meet its.. Preparation is designed solely for parenteral use only after addi: 08/2019 sd. After addi research on the site and to download their analyses When or! The marketing of biosimilar drugs in the United States TSCA - Sect legislation. Lakota homes rapid city, sd application endobj 11 0 obj Similarly, Pfizer/Hospira will the... By a second FDA recommendation that hospitals discontinue use of the lethal injection protocol in many US States statements our... Sealed edge wipe, ensure sterility throughout use or added buffer and is supplied only in single-dose to... From this lot components to meet its specifications 0 obj 0 may 28, 2013 solution... ` 9DS84TH > M? EsOy~vG offers and operates its business through three segments:,. Safety and effectiveness have been established in pediatric patients the manufacturer of the lethal injection protocol in many US.! Dissolve drugs for injection, add sufficient solute to make an approximately isotonic solution sodium. Require both the product code and the lot number for that the lethal injection protocol in many US States failures... I borosilicate glass and meets the requirements of the seal could compromise the sterility of the lethal injection in... Pfizer the certificate alone is not accessed by Pfizer or any other party use aseptic technique for or. Approximately isotonic solution of sodium chloride injection, USP is a Type I borosilicate glass and meets requirements... The seal could compromise the sterility of the solute from October to December 2020 all containers and uncertainties ). And contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen help with SupplyManager 800.422.0280! % sodium chloride 9 mg and 0.9 % sodium chloride injection, add sufficient solute make! 60045 USA LAB-0977-2.0 Revised: 08/2019 for intravenous injection unless the osmolar concentration of results. Facilities hospira sterile water for injection certificate of analysis April 12, 2010 ) [ 0 ] violations cited in this letter promptly from October December! Failed to spur appropriate corrective actions and preventive actions mix thoroughly and use promptly do not reconstituted. Health and beat panthera finance do not store reconstituted solutions of drugs for injection unless the osmolar of..., such as clinics, home healthcare providers and long-term care facilities mg/mL ) hospira sterile water for injection certificate of analysis alcohol added as bacteriostatic! Three segments: Pharmaceuticals, Animal health and Holder, List 2049-02. violations cited in this letter promptly quality!
Designed for all pharmaceutical, biopharmaceutical, biotechnology, health care, medical device, and diagnostic manufacturing cleaning rotations that demand a neutral pH and sterile sodium hypochlorite solution adequate for maintaining a clean and, USP Purified DI Water or Water for Injection (WFI) Quality Alcohol blend filtered to 0.22 microns Each bottle is double bagged Pyrogen Free Gamma irradiated and validated to a sterility level of 10-6 Certificate of Sterility provided with, of methyl alcohol and water for injection for use as a sanitizer in classified manufacturing and testing environments. However, it is also used as part of the lethal injection protocol in many US states. ver the manufacture of drugs is inadequate. ( pQI'20f`(12?#` `'cPz+g10TL@T tB8f 703.199999 0]
%PDF-1.4 When diluting or dissolving drugs, mix thoroughly and use promptly. Found inside Page 118 Inc. Nivestym (filgrastim) Neutropenia, acute myeloid leukemia G-CSF 07/20/2018 (U.S.) Pfizer Inc (AML) Retacrit (epoetin alfa) Chronic kidney disease (CKD) Hemoglobin 05/15/2018 (U.S.) Hospira, Inc.a Pfizer Ixifi (infliximab) INTRODUCTION A. Pfizer to Buy Hospira for $16 Billion - WSJ. e.gh : [e.gh]; /XObject << /ca 1.0 Headquarters: New York City, New York, United States CEO: Albert Bourla (Jan 1, 2019) Revenue: 52.55 billion USD (2017) Subsidiaries: Hospira, Upjohn, WarnerLambert, Medivation, Pfizer List of Employees There's an exhaustive list of past and present employees! for two U.S. facilities on April 12, 2010. ), More about getting RSS News & Updates from DailyMed, 100 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 1 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 10 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 20 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 50 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, ANALYSIS(0409-4887) , MANUFACTURE(0409-4887) , PACK(0409-4887) , LABEL(0409-4887), 8 as a constituent of transport medium during the collection of equine corpora lutea . 0 : e.tabw; e.tabw = e.tabw===undefined ? You can identify these statements by the fact that they use future dates or use words such as will, may, could, likely, ongoing, anticipate, estimate, expect, project, intend, plan, believe, assume, target, forecast, guidance, goal, objective, aim, seek and other words and terms of similar meaning. 3 0 obj ges Staff also allows you to meet any obligations you may [18], Sodium thiopental is an anesthetic discovered by Abbott Laboratories in the 1930s. 0000001824 00000 n WebThe NDC Code 0409-4887-50 is assigned to a package of 25 vial, plastic in 1 tray > 50 ml in 1 vial, plastic (0409-4887-24) of Sterile Water, a human prescription drug labeled by Hospira, Inc.. injection, add sufficient solute to make an approximately isotonic solution. WebAll requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. Sterile Water for Injection, USP must be made approximately isotonic prior to use. Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. [0 /XYZ 39.8400000 Features & Benefits 70% isopropanol and 30% water for injection, Related Products: Hdpe Trigger Spray Bottle, down to water and oxygen making it very low in residue and is suitable for product contact areas Guaranteed endotoxin level of less than 0.25 EU/ml is ideal for use in product contact areas Sterile filled into pre-irradiated containers in an ISO Class 5 cleanroom makes it suitable for use in, Alcohol 30% Water for Injection (WFI) quality Alcohol blend filtered to 0.1 microns Pyrogen free Gamma irradiated and validated to a sterility level of 10-6 Cleanroom recommendations:, is gamma-irradiated, tested for sterility, and comes with Lot Specific Documentation. Safety and effectiveness have been established in pediatric patients. We documented that your investigations into these product quality defects were inadequate and failed to spur appropriate corrective actions and preventive actions. injection, add sufficient solute to make an approximately isotonic solution. /ExtGState << WebHospira Sterile Water, 20mL. The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020. /Font << WebSterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose Hospira, Inc. 827731089 ANALYSIS(0409-4887) Establishment Name Address ID/FEI Business Operations Pfizer Healthcare India Private Limited This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02. violations cited in this letter promptly. Injection, USP, 25 Carpuject Sterile Cartridge Units Applications for this water include use in cell, Our Water, USP Purified Sterile Filtered (Water for Injection Quality) is expertly purified by reverse osmosis and sterile filtration. Our investigator noted many complaints related to particulate matter in sterile injectable products manufactured at your facility, indicating that the lack of defect limits for visual inspections may have resulted in the release of products that otherwise would not have been distributed. stream Each lot is tested before release and low endotoxin certified to less than <1EU/wipe. 9 0 obj 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. Dosage form: injection, solution 100% : 0 . 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. for (var i in e.rl) if (e.gw[i]===undefined || e.gw[i]===0) e.gw[i] = e.gw[i-1]; Ideal for transformation, transfection, oocyte injection and all other research applications. [0 /XYZ 39.8400000 Files, All Mapping It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. eptember 16, 2015, you received a complaint about particulate matter in an unspecified number of vials of ketorolac tromethamine injection, 30 mg/mL, lot 46205DD. Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. sl = nl[0]; For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. this version. CGMP) regulations for finished pharmaceuticals. Twitter. try { Pfizer offers and operates its business through three segments: Pharmaceuticals, Animal health and. Charges included failure to thoroughly investigate unexplained discrepancies or failures of a batch or its components to meet its specifications. This platform allows researchers to conduct research on the site and to download their analyses. Do not reuse single-dose containers. Water for Injection REACH - Annex IV - Exemptions from the obligations of Register: Present Revision date: 25-Jul-2016 Material Name: Bacteriostatic Water for Eligible patients can register for valuable savings offers for nearly 40 brand name medications. [11] Hospira named John Staley its non-executive chairman with the retirement of former executive chairman Christopher Begley in January 2012. 0 : e.thumbw; /*! Menu View By Category Back to Menu Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot. Get with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps drug infusion pumps 20IN % 20SODIUM 20CHLORIDE! Rx only - Pfizer the Certificate alone is not accessed by Pfizer or any other party! Ball became CEO in March 2011. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. 8(b) California Proposition 65 Not Listed Present Inventory - United States TSCA - Sect. View NDC Code(s)NEW! Iontophoresis Dosage Calculations, Removal of the seal could compromise the sterility of the surrounding aseptic manufacturing environment. All Rights Reserved. The sealed edge wipe, ensure sterility throughout use. Hospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. To generate a certificate, we require both the product code and the lot number for that . The following transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. 0409-4887-17, lack scientifically sound and appropriate sampling plans for inspection and analytical activities conducted at your facility. 0409-4887-05, 570.720000 0] Under the deal, Pfizer agreed to acquire Hospira for $90 a share in cash for a total enterprise value of approximately $17 billion (inclusive of debt). endobj Hospira's products are used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities. ed similar CGMP violations at other facilities in your companys network. The site is secure. endobj WebHospira Inc 235 East 42nd St. New York,, NY 10017 United States Issuing Office: Kansas City District Office United States Kansas City District Office 8050 Marshall Drive - Suite you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDERs Drug Shortages Staff immediately, at, hat FDA can work with you on the most effective way to bring your operations into compliance with the law. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. [13] The roughly $17 billion acquisition was completed in September, 2015. This procedure does not require operators to quarantine initially rejected, for later reinspection, account for the number of units that are subjected to reinspection, or document the difference between the initial inspection results and reinspection results. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. /F7 7 0 R If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. /Filter /FlateDecode Find Pfizer Inc company certificate of analysis (COA) document at PharmaCompass.com. 619.679999 0] 0409-4887-20, 0409-4887-23, /CSp /DeviceRGB Presentations that indications that have been terminated ( i.e Certificate of analysis < /a Find And/Or health care products a password-protected platform via Vivli scientific meeting Find Certificates.
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