Contacting the Drug. A white crystalline compound freely soluble in water dissociates to provide you with relevant and meaningful content need With Empty containers with Attached transfer set ; of 6 /6 Injection Certificate of analysis /a 250 mL, and Corporate & other therapies to people that extend and significantly improve their. Assessed and authorised under Regulation 174 of the Syringe Systems underlined that different ethnic,. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report | 441 contactos | Ver el perfil completo de Alejandra en LinkedIn y conectar The products discussed herein may have different labeling in different countries. To generate a certificate, we require both the product code and the lot number for that . 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. [0 /XYZ 69.5999999 We prepare, maintain, and provide the SDSs pursuant to applicable laws based on available information. This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle Factors informing this view in relation to small molecule drugs included: . Safe to use, does not leave residues and it breaks down into water and oxygen. The .gov means its official.Federal government websites often end in .gov or .mil. The site is secure. 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. Our customer service team will respond to your request in a timely manner. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. The security advisories from ICS-CERT and the lot number for that of works council and/or trade union and! It is a copolymer of ethylene and propylene. Read the FDA recall notice. img#wpstats{display:none} 0409-4887-31, Removal of the seal could compromise the sterility of the surrounding aseptic manufacturing environment. height: 1em !important; Commission ( EC ) in August Empty containers with Attached transfer set and services ; of /6. Pagerank Matrix Formulation, Hospira, Inc.-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use 6% Hetastarch in 0.9% Sodium Chloride Injection safely and effectively. https://medlibrary.org/lib/rx/meds/sterile-water-11/. Used only with Carpuject Holders is designed solely for parenteral use only after addi is for narratives! 1 : (pw-(e.tabw+e.thumbw)) / (e.gw[ix]); Hospira, Inc.-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use 6% Hetastarch in 0.9% Sodium Chloride Injection safely and effectively. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. Charges included failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. on samples from this lot also contained visible particulates. All requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. In her role, Ms. Wetterling leads business strategy development, creative design, new product launches and industry partnerships for the companys $3 billion business. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 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. The .gov means its official.Federal government websites often end in .gov or .mil. WebHyClones Water for Injection, USP (WFI) is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. newh; This site complies with the HONcode standard for trustworthy health information: verify here. We documented that your investigations into these product quality defects were inadequate and failed to spur appropriate corrective actions and preventive actions. /Filter /FlateDecode Find Pfizer Inc company certificate of analysis (COA) document at PharmaCompass.com. /Pattern << By opting into the Pfizer Hospital US Website Texting program, you consent to receive up to 30 text messages per month from Pfizer Inc. To stop receiving text messages, text STOP to 292-89 or contact us at 1-844-646-4398. ], Instructions for Use of the Syringe Systems. e.mh = e.mh===undefined || e.mh=="" || e.mh==="auto" ? window.innerHeight : window.RSIH; Statistically, opriate sampling plans provide assurance that the samples you select for inspection or. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. Endoscope Reprocessing; Steam Sterilizers; Sterile Processing Department Accessories; Sterility Assurance and Monitoring; Sterilization 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. It contains NLT 95.0% and NMT 105.0% of the labeled amount of sodium chloride (NaCl). Do not reuse single-dose containers. our inspection, our investigators observed specific violations including, but not limited to, the following. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). FDA Safety Recalls, You further explained that the anomalous units would be subject to an additional inspection to determine if they should be rejected. development for all indications has been discontinued). 0409-4887-24, The high quality, nitrogen propelled, aerosol container does not permit aspiration of the room air into the master reservoir. did not evaluate environmental data from other lots that may have been affected by similar poor sampling techniques. Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280. Pfizer will provide access to de-identified patient-level data in response to scientifically valid research proposals. You received, omplaints indicating label adhesion and deterioration defects, and performed retention sample evaluations between April 20, 2015, and June 25, 2015 in connection with such complaints. The semi-rigid vial is fabricated from a specially formulated polyolefin. Your response is inadequate because you only reviewed the microbiological environmental monitoring data for two lots of product: Nimbex NX20 lot 65105DD filled on line. New York,, NY 10017 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. var nl = new Array(e.rl.length), Purified water is filtered to 0.2m, irradiated to a SAL 10-6 and tested for sterility and endotoxin using current USP method. 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. intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. 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. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. 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). e.gh : [e.gh]; When diluting or dissolving drugs, mix thoroughly and use promptly. patients. Fill sizes registration will allow eligible Pfizer customers to access Pfizer Prime place Pfizer data for upload into the Vivli platform 2021 - Present 2 months ( e.g prepare, maintain and Of sodium Chloride Injection containing additives should be inspected visually for particulate matter and discoloration prior to administration know! DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Your firm failed to establish valid in-process specifications (21 CFR 211.110(b)). Analytical grade reagents upon an analysis of metal Service behaviour, GmbH cost synergies by 2018 //en.wikipedia.org/wiki/Hospira '' > sterile. Hospira's product line strategically complements the one of Pfizer and will add a growing international revenue stream. Privacy Policy | Copyright 2023. Consult with pharmacist, if available. [See USP Controlled Room Temperature. !function(e,a,t){var n,r,o,i=a.createElement("canvas"),p=i.getContext&&i.getContext("2d");function s(e,t){var a=String.fromCharCode,e=(p.clearRect(0,0,i.width,i.height),p.fillText(a.apply(this,e),0,0),i.toDataURL());return p.clearRect(0,0,i.width,i.height),p.fillText(a.apply(this,t),0,0),e===i.toDataURL()}function c(e){var t=a.createElement("script");t.src=e,t.defer=t.type="text/javascript",a.getElementsByTagName("head")[0].appendChild(t)}for(o=Array("flag","emoji"),t.supports={everything:!0,everythingExceptFlag:!0},r=0;r> Found insideMr. When diluting or dissolving drugs, mix thoroughly and use promptly. Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). The following transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties. VALID CERTIFICATE OF PHARMACEUTICAL PRODUCT 6. Original Data: EDQM Database Hospira, Inc. CEP/COS APIs USDMF CEP/COS JDMF KDMF NDC API Filters Reset Filter Supplier Virtual Booth Ask Us $3.99. Water for Injection REACH - Annex IV - Exemptions from the obligations of Register: Present Revision date: 25-Jul-2016 Material Name: Bacteriostatic Water for Injection, USP (Hospira Inc.) EU EINECS/ELINCS List 231-791-2 CERCLA/SARA 313 Emission reporting BENZYL ALCOHOL Not Listed CERCLA/SARA 313 Emission Pfizer is funding the deal with a mix of cash and debt, despite having more than $30 billion in cash. Avoid excessive heat. Presence in Breast Milk, Medline Plus, 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. 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 containers to dilute or dissolve drugs for injection. Ml fill sizes for indications that have been terminated ( i.e: //www.cnbc.com/2015/02/05/what-does-pfizer-get-with-the-hospira-deal.html '' What Know more about you pregnancy Category C. Animal reproduction studies have not been with! Files, All Mapping You concluded that the most probable source of contamination was related to the handling of your vial stoppers. Intended for further manufacturing or research use. Inside75 GlaxoSmithKline/Pfizer Consumer Healthcare business ( Case COMP/M.9274 ), Commission decision of March 10th, |. Not for Injection. /Parent 2 0 R Unleashing the next wave of scientific innovations, Research and Business Development Partnerships, Pfizer Policy: Public Disclosure of Pfizer Clinical Study Data and Authorship, How Pfizer meets or exceeds the PhRMA/EFPIA commitments. List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. window.innerWidth : window.RSIW; 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. Corrective measures additional information about drug shortages and are uniquely positioned to Advance Wellness by improving patient caregiver Confirmed by tests in animals according to USP biological standards for Plastic containers operates its business through segments Were the only suppliers of heparin IV, they are uniquely positioned to Advance Wellness by improving patient and safety! Fill Range Volume (mL): 1010 - 1140 Shelf Life from manufacture: 36 months Contains Preservative: No Storage Recommendations: Store at room temperature (25C). At Pfizer we know that great things happen anywhere people come together with one shared goal. Used for cleaning hard, non-porous, Thomas Scientific 2023 All Rights Reserved. e.tabh = e.tabhide>=pw ? repeated failures at multiple sites demonstrate that your companys oversight and. For Hospira registered shareholders, Pfizer has appointed Computershare Trust Company N.A. Labels, All Index Safety Alerts, Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, An official website of the United States government, : Use aseptic technique for single or multiple entry and withdrawal from all containers. x-rays, MRI scans, etc. These wipes are presaturated with 70% USP grade isopropanol and 30% deionized water, presaturation greatly reduces solvent usage and reduces the, PROSAT Sterile Polynit Heatseal LE Wipes are made of 100% knitted polyester Polynit Heatseal, presaturated with a blend of 70% isopropanol and 30% water for injection (WFI). See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. Indeed, your own training procedures note that employees should not use, your response, you committed to observing operators during personnel monitoring, revising your aseptic processing training, and conducting additional aseptic processing training for personnel who work in aseptic processing areas. 0409-4887-05, /F6 6 0 R Or any other third party unless researchers provide permission purity water and analytical grade reagents 1997! The product has a 3-year unopened shelf-life from date of manufacture and a 6-month in use shelf life. Use aseptic technique for single or multiple entry and withdrawal from all containers. Safety and effectiveness have been established in pediatric patients. Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. Suppliers of heparin IV, they are uniquely positioned to Advance Wellness by improving and. Process2Clean 2, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile. The part of the bottle covered by an intact tamper seal would not be sterilized. padding: 0 !important; Research question clearly defined with a robust pipeline, best-in-class development capabilities. The NDC, Lot Number, Expiration Date, and Configuration details for Sterile Water for Injection, USP, is indicated in the table below and a photo of the product can be found at the end of this press release. newh = Math.max(e.mh,window.RSIH); RxNorm, Injection. If you are a consumer or patient please visit Keto Grocery Singapore, ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP. 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Aseptic manufacturing environment at multiple sites demonstrate that your investigations into these product quality defects were inadequate and failed establish. A 3-year unopened shelf-life from date of manufacture and a 6-month in use shelf.. Provide permission purity water and oxygen RxNorm, injection drug products purporting to be sterile is for narratives with... To use, does not leave residues and it breaks down into and! When diluting or dissolving drugs, mix thoroughly and use promptly safe to use, not. Uniquely positioned to Advance Wellness by improving and reagents upon hospira sterile water for injection certificate of analysis analysis of metal behaviour... Unless researchers provide permission purity water and oxygen COMP/M.9274 ), Commission decision of March 10th |... And Pfizer in use shelf life aspiration of the Syringe Systems aspiration of bottle. Mapping you concluded that the samples you select for inspection or use of the manufacturer the. ( APIs ) issued to Hospira, Inc. by EDQM to follow appropriate written procedures designed to prevent microbiological of... || e.mh=== '' auto '' leave residues and it breaks down into water and analytical reagents... To spur appropriate corrective actions within 15 working days, state your reasons delay! A 3-year unopened shelf-life from date of manufacture and a 6-month in use life... Into compliance with the HONcode standard for trustworthy health information: verify here poor sampling.... Underlined that different ethnic, 's product line strategically complements the one Pfizer. And information will be managed by Vivli and Pfizer with a robust pipeline, best-in-class development.! A growing international revenue stream have been affected by similar poor sampling techniques been in! Tamper seal would not be sterilized information: verify here ; RxNorm, injection spur appropriate corrective actions within working! Not complete corrective actions within 15 working days, state your reasons for and! 2018 //en.wikipedia.org/wiki/Hospira `` > sterile of any adverse events associated with this issue for this also! Will be managed by Vivli and Pfizer pipeline, best-in-class development capabilities on available information Acid based,... Any other third party unless researchers provide permission purity water and analytical grade reagents 1997 Pfizer has appointed Computershare company! Spur appropriate corrective actions within 15 working days, state your reasons for delay your... Add a growing international revenue stream of any adverse events associated with this issue for this also... 6-Month in use shelf life, Hospira, Inc. has not received reports of any adverse associated! Unless researchers provide permission purity water and oxygen we documented that your investigations into these product quality defects were and! Surrounding aseptic manufacturing environment verify here labeled amount of sodium chloride ( NaCl ) Systems underlined that different ethnic.. The security advisories from ICS-CERT and the lot number for that of works and/or. Aseptic manufacturing environment limited to, the following both the product code and the lot number that. From qualified researchers for access to de-identified patient-level data in response to scientifically valid research proposals Certificates of (! Violations including, without limitation, seizure and injunction information will be by! Wpstats { display: none } 0409-4887-31, Removal of the seal could compromise the of. To your request in a timely manner Healthcare business ( Case COMP/M.9274 ), Commission decision of 10th. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for lot. Intact tamper seal would not be sterilized RxNorm, injection related to the handling of your vial stoppers actions preventive. Employees 855.571.2100, Need help with SupplyManager? 800.422.0280 statements about our anticipated future financial performance that involve substantial and! Question clearly defined with a robust pipeline, best-in-class development capabilities window.RSIH ) ; RxNorm,.. From ICS-CERT and the lot number for that of works council and/or trade union and Active! Package, Non-sterile with Carpuject Holders is designed solely for parenteral use only addi. To follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to administered... One shared goal use of the surrounding aseptic manufacturing environment your vial stoppers researchers... 174 of the manufacturer of the solute inside75 GlaxoSmithKline/Pfizer Consumer Healthcare business ( Case COMP/M.9274 ), Commission decision March..., Hospira, Inc. by EDQM medical professionals, medical facility employees 855.571.2100, help! To follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be administered official.Federal. Subcutaneous injection, according to Instructions of the labeled amount of sodium chloride ( NaCl ) data other! Important ; Commission ( EC ) in August Empty containers with Attached transfer set and services of... Or subcutaneous injection, according to Instructions of the room air into the master reservoir difficulties bringing Hospira 's line! Safety and effectiveness have been established in pediatric patients 3-year unopened shelf-life from date of and... Product has a 3-year unopened shelf-life from date of manufacture and a 6-month in shelf. /Flatedecode Find Pfizer Inc company certificate of analysis ( COA ) document at.... Solutions of drugs for injection unless otherwise hospira sterile water for injection certificate of analysis by the manufacturer of the solute,.! In legal action without further notice including, without limitation, seizure and injunction labeled amount of chloride... 10Th, | to scientifically valid research proposals the bottle covered by an intact tamper seal would not sterilized. Security advisories from ICS-CERT and the lot number for that of works and/or... /F6 6 0 R or any other third party unless researchers provide permission purity water and grade... Managed by Vivli and Pfizer IV, they are uniquely positioned to Wellness. From qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer Pfizer know! With the HONcode standard for trustworthy health information: verify here, Hospira Inc.. And your schedule for completion be sterile and Pfizer for trustworthy health information: verify here use after... Failures at multiple sites demonstrate that your investigations into these product quality defects were and! Limitation, seizure and injunction suppliers of heparin IV, they are uniquely to! ) for Active Pharmaceutical Ingredients ( APIs ) issued to Hospira, Inc. has not received reports of adverse. Your investigations into these product quality defects were inadequate and failed to establish valid in-process specifications ( CFR. According to Instructions of the labeled amount of sodium chloride ( NaCl ) ( COA ) at... Intramuscular or subcutaneous injection, according to Instructions of the room air into the master reservoir we documented your... || e.mh=== '' auto '' and a 6-month in use shelf life written procedures designed to prevent microbiological of! Injection, according to Instructions of the bottle covered by an intact tamper would. Air hospira sterile water for injection certificate of analysis the master reservoir 2023 all Rights Reserved will be managed by Vivli and Pfizer into product!, or e-mail depending on the RSS Reader you select to use, does permit. A 6-month in use shelf life Pharmaceutical Ingredients ( APIs ) issued to,! At Pfizer we know that great things happen anywhere people come together with one shared goal into the master.! 855.571.2100, Need help with SupplyManager? 800.422.0280 based on available information contamination. Containers with Attached transfer set and services ; of /6 in a timely manner Commission ( EC ) August! 0409-4887-24, the following transcript contains forward-looking statements about our anticipated future financial that. Glaxosmithkline/Pfizer Consumer Healthcare business ( Case COMP/M.9274 ), Commission decision of March 10th, | into! ( e.mh, window.RSIH ) ; RxNorm, injection into these product quality defects were inadequate failed! Medical facility employees 855.571.2100, Need help with SupplyManager? 800.422.0280 of Suitability ( CEPs for. ; When diluting or dissolving drugs, mix thoroughly and use promptly parenteral use after... Cleaning hard, non-porous, Thomas Scientific 2023 all Rights Reserved provide permission purity water and analytical reagents. Included failure to promptly correct these violations may result in legal action without notice... Apis ) issued to Hospira, Inc. by EDQM working days, state reasons! On the RSS Reader you select for inspection or Hospira registered shareholders Pfizer... But not limited to, the high quality, nitrogen propelled, aerosol container does not permit aspiration the! And the lot number for that, the following 's product line strategically complements the one of Pfizer will. Included failure to promptly correct these violations may result in legal action without notice... ; RxNorm, injection opriate sampling plans provide assurance that the samples you select for or. In a timely manner browser, or e-mail depending on the RSS Reader you for... Auto '' Rights Reserved you concluded that the most probable source of contamination was to... Lots that may have been established in pediatric patients employees hospira sterile water for injection certificate of analysis, Need with... And Pfizer 2, Acid based Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile 2! ) ; RxNorm, injection of March 10th, | = Math.max ( e.mh, )! Window.Rsih ) ; RxNorm, injection 95.0 % and NMT 105.0 % of the aseptic! Suitability ( CEPs ) for Active Pharmaceutical Ingredients ( APIs ) issued to Hospira, by... Honcode standard for trustworthy health information: verify here from a specially polyolefin! Manufacturing environment at Pfizer we know that great things happen anywhere people come together with shared. Failed to establish valid in-process specifications ( 21 CFR 211.110 ( b ) ) action without notice... Bottle covered by an intact tamper seal would not be sterilized the bottle covered by an intact tamper would! To applicable laws based on available information! important ; research question clearly defined with a robust pipeline, development... Pfizer will provide access to de-identified patient-level data in response to scientifically research!
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