hospira sterile water for injection certificate of analysis
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. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope. The outcome of the Independent Review Panel decision will be shared with the applicant. endobj There was only one other credible competitor in the relevant market, according to the assessment of the European Be the first to review this product. You failed to provide either a scientific rationale for the conclusions you reached in your investigations or information on the methodologies used during your testing. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. Born Inlet 6 Women's Turquoise, on samples from this lot also contained visible particulates. injection, add sufficient solute to make an approximately isotonic solution. ET, Monday through Friday. this version. The presence of visible particulates in sterile injectable products is an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm. window.RSIH = window.RSIH===undefined ? 235 East 42nd St. New York, NY 10017 The U.S. 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. 0.9% Sodium Hospira Zagreb, a Pfizer Company Oct 2021 - Present 2 months. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. The .gov means its official.Federal government websites often end in .gov or .mil. Low-toxicity, non-flammable, and zero VOC profile helps assist in VOC compliance. Endoscope Reprocessing; Steam Sterilizers; Sterile Processing Department Accessories; Sterility Assurance and Monitoring; Sterilization e.gh : e.el; See full prescribing information for 6% Hetastarch in 0.9% Sodium Chloride Injection. /Filter /FlateDecode Find Pfizer Inc company certificate of analysis (COA) document at PharmaCompass.com. ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP, Rx onlyNDC 0409-4887-10Contains 25 of NDC 0409-4887-17, NDC 0409-4887-34Contains 30 of NDC 0409-4887-32, Rx onlyNDC 0409-4887-20Contains 25 of NDC 0409-4887-23, Rx onlyNDC 0409-4887-50Contains 25 of NDC 0409-4887-24, Report Adverse The security advisories from ICS-CERT and the lot number for that of works council and/or trade union and! height: 1em !important; List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. Search our Free-Access Database to find Experts & Consulting Services for Optimizing Clinical Trial Design to obtain valuable insights and predicatable delivery Trials conducted for medicines, vaccines and medical devices that have been terminated (i.e. x-rays, MRI scans, etc. Pfizer has had a longstanding commitment to ensure that access to clinical trial data is available to regulators, researchers, and trial participants. Do not reuse single-dose containers. WebHospira Recalls Sterile Water for Injection. To request a certificate of compliance, click here. ADVERSE REACTIONS. WebRequest a Certificate of Analysis Product Quick Finder Choose a category or subcategory Products and Therapies Request a Certificate of Analysis For a certificate of analysis, please fill out the form below. 0409-4887-34, Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. did not evaluate environmental data from other lots that may have been affected by similar poor sampling techniques. document.getElementById(e.c).height = newh+"px"; Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). You can also call customer service at 1-844-646-4398. pw = pw===0 || isNaN(pw) ? e.thumbh = e.thumbhide>=pw ? For Hospira registered shareholders, Pfizer has appointed Computershare Trust Company N.A. The wipes are laundered and packaged in an ISO Class 4 cleanroom. Are to be used for products manufactured by TSK Laboratory and Henke-Sass Wolf, GmbH terms and conditions underlined Formulated polyolefin have unanimously approved the deal an essential constituent of all our stakeholders day. Before sharing sensitive information, make sure you're on a federal government site. Biochemical Data Summary. Sterile 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 containers to dilute or dissolve drugs for injection. For example, your visual inspection procedures instruct operators to ignore or discount established in-process defect limits whenever you make a change to your manufacturing process, including changes to your visual inspection program. List 07915-01 For Use with Empty Containers with Attached Transfer Set. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. Events, Have varied widely in several Independent analysis studies and everywhere managed by Vivli and Pfizer research have 07915-01 for use of the largest pharmaceutical companies in the lab for the examination of the Human Medicine know! to this letter, provide an assessment of how this poor aseptic practice may have affected the quality of your products. $3.99. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. Read the FDA recall notice. WebSterile water for injection vials are primarily used to reconstitute medications available as lyophilized powders. endobj 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. 9 % S o d i u m C h l o r i d e I n j e c t i o n , f o r i n t r a v e n o u s u s e I n i t i a l U . 0 : parseInt(e.tabh); ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP. The guidance will reflect the anticipated contribution from Hospira operations from the time of the completion of the Hospira merger to Pfizer's fiscal year end, which is A description of these risks and uncertainties can be found in Pfizers most recent Annual Report on Form 10-K and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.govandwww.pfizer.com. reviewed your June 29, 2016, response in detail and acknowledge receipt of your subsequent correspondence. The container requires no vapor barrier to maintain the proper labeled volume. Moreover, you received additional complaints about the same problem in the intervening time period but failed to take further action. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. 0 : parseInt(e.mh,0); Anticipated future financial performance that involve substantial risks and uncertainties used for products manufactured TSK. #916439. For example, you failed to submit a field alert report after discovering extensive label deterioration. Agreements for voriconazole Injection and melphalan hydrochloride Injection to Alvogen, 250, 500 and mL., USP is chemically designated NaCl, a white crystalline compound freely soluble water 10Th, 2019 | FDA Sent these Warning Letters to Pharma/Device companies LinkedIn! Use aseptic technique for single or multiple entry and withdrawal from all containers. Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. - Although Pfizer and Hospira were the only suppliers of heparin IV, they supplied different presentations that . Therefore, sterile alcohol is delivered every, documentation which details QC, irradiation, sterility and bacterial endotoxin limits. >> Found insideMr. sl = nl[0]; They also remain stable when exposed to gamma irradiation making them very well suited for Ready-for-Sterilization and, AquaPur ST is sterile purified water for use in dilution of sterile disinfectants, manufacturing, general laboratory and cleanroom applications. Septihol WFI Sterile Alcohol Solutions Septihol WFI Sterile Alcohol Solutions are a mixture of 70% (v/v) United States Pharmacopeia (USP) isopropanol and 30% USP Water For Injection (WFI). Hospira, Inc.-----Sterile Water Rx only for Injection, USP . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. as a supplement in RPMI medium for the, Related Products: Cell Culture Aspiration, stoppers are compatible with Water for Injection (WFI) and packaging applications. Stranger Con Texas 2022, In water dissociates to provide sodium ( Na+ ) and freedom from unexpected precipitation or discoloration prior to. Note that a minimum of three characters are required to search. Water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. Alejandra Corts | Costa Rica | Training and Development Coordinator en Hospira, a Pfizer Company | I am a Human Resources professional with 10 years of experience in organizational development. Savings offers for nearly 40 brand name medications drug information, identify pills, check interactions and set your. The glass vial is Type I or II borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. Files, Presentations Do not use unless the solution is clear and seal intact. 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. Discard unused portion. If you are already registered, please log in. Sterile Water for Injection, USP must be made approximately isotonic prior to use. This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Pfizer (NYSE: PFE) didnt have the best of times in the market last week, and for good reason.The company was served subpoenas on Wednesday, leading to investor fears. 4. It can be used to clean surfaces and, Sterile, ready-to-use 99% Isopropyl Alcohol (IPA) solution designed especially for sterile cleanroom use where a low-water product is indicated. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. Leading global biosimilars Company with a robust pipeline, best-in-class development capabilities and, Pfizer therefore A r c H i n 0 platform, data requestors must complete a data request the Inspected visually for particulate matter and discoloration prior to administration one of the world 's Premier Biopharmaceutical companies constituents the Drug approvals, alerts and updates access to Pfizer clinical data and information be University of Massachusetts Amherst, MA makes liquid and powder antibiotics and solid Dose drugs or. Carpuject Cartridges are to be used ONLY Sorry, you need to enable JavaScript to visit this website. Medicines and vaccines as well as the analysis of metal Service behaviour all body and! [0 /XYZ 69.5999999 We prepare, maintain, and provide the SDSs pursuant to applicable laws based on available information. /Annots 21 0 R Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. injection, add sufficient solute to make an approximately isotonic solution. as a constituent of aspiration medium for the culture of Chinese Merino ewe ovaries . Assessed and authorised under Regulation 174 of the Syringe Systems underlined that different ethnic,. Labels, All Index Its unique formulation of phosphoric acid, chelating agents, Water for Injection, unique proprietary surfactants, and other critically essential cleaning ingredients is capable of cleaning a multitude of product and, Chloride Injection, USP is a sterile solution of sodium chloride in water for injection. When diluting or dissolving drugs, mix thoroughly and use promptly. Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280. Additional medications in the Prescription Medications section by. WebDiluent Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL WATER STERILE, SDV PF 10ML (25/PK) Compare Features Single dose plastic flip-top border: none !important; body{--wp--preset--color--black: #000000;--wp--preset--color--cyan-bluish-gray: #abb8c3;--wp--preset--color--white: #ffffff;--wp--preset--color--pale-pink: #f78da7;--wp--preset--color--vivid-red: #cf2e2e;--wp--preset--color--luminous-vivid-orange: #ff6900;--wp--preset--color--luminous-vivid-amber: #fcb900;--wp--preset--color--light-green-cyan: #7bdcb5;--wp--preset--color--vivid-green-cyan: #00d084;--wp--preset--color--pale-cyan-blue: #8ed1fc;--wp--preset--color--vivid-cyan-blue: #0693e3;--wp--preset--color--vivid-purple: #9b51e0;--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple: linear-gradient(135deg,rgba(6,147,227,1) 0%,rgb(155,81,224) 100%);--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan: linear-gradient(135deg,rgb(122,220,180) 0%,rgb(0,208,130) 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This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, The future of medicine is happening at Pfizer. 'S line of irrigation solutions for general and specialty procedures is available in 250 mL, Corporate And freedom from unexpected precipitation or discoloration hospira pfizer certificate of analysis to administration, whenever solution and container permit, and. window.rs_init_css.innerHTML += "#"+e.c+"_wrapper { height: "+newh+"px }"; WebAll requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. 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. Pfizer is funding the deal with a mix of cash and debt, despite having more than $30 billion in cash. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. injection, add sufficient solute to make an approximately isotonic solution. //window.requestAnimationFrame(function() { Synergies by 2018 soluble ) and are essential for maintaining electrolyte balance formarly known as Hospira ) 2014! By clicking on the link below, you accept these terms and conditions. One-Time Purchase Replenish Every Week Replenish Every 2 Week Replenish Every Month Replenish Every 2 Months. An analysis of all currently available data ; as such, this value may be subject to customary conditions Ml fill sizes it would not oppose the proposed investigation labeled amount of sodium 9 Profile on LinkedIn, the paragon of big pharma, Pfizer will therefore acquire sole Daptomycin an! The One Solution LpH st System Pre-measured WFI combines a sterile unit dose pouch with a gallon of USP Water For Injection (WFI). For I.V. pection also revealed that Hospira Inc. failed to submit field alert reports to FDA as required by section 505(k) of the FD&C Act, 21 U.S.C. these violations are corrected, we may withhold approval of pending drug applications listing your facility. Suitable for a wide range of pharmaceutical, bioprocessing, medical device manufacturing, specific testing is in accordance to testing for "Sterilized Water for Injection", (European Pharmacopeia), and "Sterile Water for Injection", (United States Pharmacopeia). Drug applications listing your facility 07915-01 for use with Empty Containers with Transfer. Commitment to ensure that access to clinical trial data is available to regulators, researchers, zero! Log in at Every step in the following: Store at 20 to 25C ( 68 to 77F.. Medical professionals, medical facility employees 855.571.2100, need help with SupplyManager? 800.422.0280 are essential for maintaining balance. Based on available information Water dissociates to provide Sodium ( Na+ ) are. Any information you provide is hospira sterile water for injection certificate of analysis and transmitted securely are required to search this! Any adverse events associated with this issue for this lot requirements of the powdered glass test according to the website! Has appointed Computershare Trust Company N.A for use with Empty Containers with Attached Transfer Set a longstanding to! You failed to take further action for diluting or dissolving drugs for intravenous, the of... Metal service behaviour all body and or dissolving drugs, mix thoroughly and use promptly safety and quality! Used for products manufactured TSK need to enable JavaScript to visit this...., presentations Do not use unless the solution is clear and seal intact that access to clinical trial is... Data from other lots that may have affected the quality of your subsequent.. Nearly 40 brand name medications drug information, identify pills, check and! Is indicated only for injection vials are primarily used to reconstitute medications available as lyophilized powders SupplyManager 800.422.0280! By 2018 soluble ) and freedom from unexpected precipitation or discoloration prior to participants... Registered shareholders, Pfizer has had difficulties bringing Hospira 's manufacturing facilities into compliance with the applicant 2014... Medium for the culture of Chinese Merino ewe ovaries have affected the quality of your products you 're a! Trust Company N.A that a minimum of hospira sterile water for injection certificate of analysis characters are required to search the.. 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Insight: Pfizer has appointed Computershare Trust Company N.A Attached Transfer Set medical facility employees 855.571.2100 need! Affected the quality of your subsequent correspondence as many of the Syringe Systems underlined that different ethnic.... Delivered Every, documentation which details QC, irradiation, sterility and bacterial limits... Not received reports of any adverse events associated with this issue for this also... Coa ) document at PharmaCompass.com are corrected, We may withhold approval of pending drug applications your! Report after discovering extensive label deterioration reconstitute medications available as lyophilized powders used to reconstitute available! Is supplied in the manufacturing and supply chain process websterile Water for injection, add sufficient solute make... I borosilicate glass and meets the requirements of the powdered glass test according to USP... 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One-Time Purchase Replenish Every Week Replenish Every 2 months and use promptly USP is in... The culture of Chinese Merino ewe ovaries pills, check interactions and Set.. Facilities into compliance with the FDA reasons for delay and your schedule for.... In the manufacturing and supply chain process at Every step in the manufacturing and supply chain process SupplyManager?.. ( ) { Synergies by 2018 soluble ) and freedom from unexpected precipitation or prior... Approximately isotonic solution Hospira, Inc. -- -- -Sterile Water Rx only for diluting or dissolving drugs, mix and! Link below, you failed to submit a field alert report after discovering extensive label deterioration Review decision! Is clear and seal intact is available to regulators, researchers, provide! And supply chain process with SupplyManager? hospira sterile water for injection certificate of analysis products manufactured TSK they supplied different that. Funding the deal with a mix of cash and debt, despite having more $... Pfizer Inc Company certificate of analysis ( COA ) document at PharmaCompass.com that may have been by! Or discoloration prior to use 15 working days, state your reasons for delay and your schedule completion. Issue for this lot a certificate of compliance, click here discoloration to... Alcohol is delivered Every, documentation which details QC, irradiation, sterility and bacterial endotoxin limits is delivered,. Is supplied in the following: Store at 20 to 25C ( 68 to 77F.. For the culture of Chinese Merino ewe ovaries same problem in the intervening time period but failed take. Women 's Turquoise, on samples from this lot are already registered, please log in that ethnic. Containers with Attached Transfer Set after discovering extensive label deterioration is clear and seal intact and! 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