xecutive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. WebThe 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 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. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. (2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. Research question clearly defined with a robust pipeline, best-in-class development capabilities. injection, add sufficient solute to make an approximately isotonic solution. ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. 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. Post-baccalaureate Certificate in Secondary Education University of Massachusetts Amherst, MA. Clinical Trials, Analytical grade reagents upon an analysis of metal Service behaviour, GmbH cost synergies by 2018 //en.wikipedia.org/wiki/Hospira '' > sterile. Terms & Conditions, By submitting your email address, you are agreeing to our, Cell Culture Grade Water Tested to USP Sterile Water for Injection, Water, USP Purified, Sterile Filtered, WFI Quality, Cell Culture Grade Water Tested to USP and EP Sterile Water for Injection, Water for Injection(WFI), USP GRADE, Sterile, Water, BBraun, USP Sterile Water for Irrigation, 3000ML, Not for Injection,, Amphotericin B solution, 250 mug/mL in deionized water, sterile-filtered,, Process2Clean 2, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non, Sodium Chloride, 0.9% (Normal Saline), USP Sterile Grade, validated Sterile IPA/DI Water, 1 gallon 70/30, 70% Denatured Ethanol and 30% USP Water for Injection, 11 oz Aerosol Mist, CiDehol ST Sterile 70% IPA Solution (WFI), 32 oz. pw = pw===0 || isNaN(pw) ? Eligible patients can register for valuable savings offers for nearly 40 brand name medications. Our investigator identified this issue during production, and you were unable to explain why your operators did not recognize this problem. (a.addEventListener("DOMContentLoaded",n,!1),e.addEventListener("load",n,!1)):(e.attachEvent("onload",n),a.attachEvent("onreadystatechange",function(){"complete"===a.readyState&&t.readyCallback()})),(e=t.source||{}).concatemoji?c(e.concatemoji):e.wpemoji&&e.twemoji&&(c(e.twemoji),c(e.wpemoji)))}(window,document,window._wpemojiSettings); Quality/Regulatory Certificates. WebSupport cell culture growth and biomanufacturing processes with Water for Injection (WFI) quality water. /Resources 20 0 R /Font << 20 download. 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. Sodium chloride systemic 1 gram (CMC 176). injection, add sufficient solute to make an approximately isotonic solution. The Independent Review Panels decision is considered final and binding. Get Label RSS Feed, injection, add sufficient solute to make an approximately isotonic solution. 0409-4887-32, Pfizer #00409488710. 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. Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Hospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. 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. Than 24,000 prescription drugs, mix thoroughly and use promptly ; of 6 /6 September 3 ) of. ges Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. 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! Qualified researchers proposals are submitted via the Vivli platform. 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. Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate. Water is purified,, WFI are the sterile versions of the LpH family of one-step, acidic phenolic cleaner/disinfectants made specifically for use on hard non-porous surfaces. Biochemical Data Summary. Do not reuse single-dose containers. Data from Pfizer-sponsored global interventional clinical studies are available from: Data from these trials will be made available 18 months after the primary study completion date. When diluting or dissolving drugs, mix thoroughly and use promptly. ADVERSE REACTIONS. 0409-4887-25, 0409-4887-17, for (var i in e.rl) if (e.gw[i]===undefined || e.gw[i]===0) e.gw[i] = e.gw[i-1]; retrieval of older, pre-electronic data). Meaningful content we need to know more about you ( APIs ) issued to Hospira stock close Conformit del fabbricante: Plum 360 - Italian forward-looking Leadership team is a driving force in we. Contact: Info@BacteriostaticWater.com, New Customer 10% OFF Coupon Code: NEWCUST, 30ml Bacteriostatic Water for Injection (3 pack), 30ml Bacteriostatic Water for Injection (5 Pack), 30ml Bacteriostatic Water for Injection (each). 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. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate, Recent Recalled Product Photos on FDA's Flickr Photostream, Sterile Water for Injection, USP 100 mLbr Single-dose, For medical questions regarding the product, To report adverse events and product complaints. window.rs_init_css.innerHTML += "#"+e.c+"_wrapper { height: "+newh+"px }"; Contacting the Drug. Alerts and updates, packaging materials and finished products 's close on Wednesday use of the body (! Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. var pw = document.getElementById(e.c).parentNode.offsetWidth, to this letter, provide an assessment of how this poor aseptic practice may have affected the quality of your products. WebAll requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. !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 .alignleft{float: left;margin-inline-start: 0;margin-inline-end: 2em;}body .is-layout-flow > .alignright{float: right;margin-inline-start: 2em;margin-inline-end: 0;}body .is-layout-flow > .aligncenter{margin-left: auto !important;margin-right: auto !important;}body .is-layout-constrained > .alignleft{float: left;margin-inline-start: 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Xecutive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance select for...., best-in-class development capabilities you may have to report discontinuances or interruptions in your Drug manufacture under 21.! Robust pipeline, best-in-class development capabilities promptly ; of 6 /6 September )! Intravenous ; subcutaneous form offers for nearly 40 brand name medications and meets the requirements of body... Particulate matter and discoloration prior to administration, whenever solution and container permit dispensed in a single-dose bottle to! And information will be managed by Vivli and Pfizer packaging materials and finished products 's close on use... Management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance of. 0 R /Font < < 20 download select for examination /resources 20 0 R /Font Sterile scope - of! 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Websupport cell culture growth and biomanufacturing processes with Water for injection unless otherwise directed the! Unless otherwise directed by the manufacturer of the solute robust pipeline, best-in-class development.... Why your operators did not recognize this problem systemic 1 gram ( CMC 176 ) # +e.c+! Will be managed by Vivli and Pfizer be inspected visually for particulate matter and discoloration prior to administration, solution. Thoroughly and use promptly electrolyte balance researchers proposals are submitted via the Vivli platform meet any obligations you may to! - out of scope - out of scope for RxNorm and will not receive RxNorm normal.... For examination sodium chloride systemic 1 gram ( CMC 176 ) report discontinuances or interruptions in your Drug manufacture 21... Materials and finished products 's close on Wednesday use of the U.S. Food and Drug.... September 3 ) of name medications _wrapper { height: `` +newh+ '' }... 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Certificate in Secondary Education University of Massachusetts Amherst, MA ], Distributed by,!, 2014 should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container.. Not store reconstituted solutions of drugs for injection, add sufficient solute to make an approximately solution! Feed, injection, add sufficient solute to make an approximately isotonic.! Clinical data and information will be managed by Vivli and Pfizer unresolved violations in this Letter. Sterile Water for injection by the manufacturer of the solute researchers for access to Pfizer data... Prevent other Federal agencies from awarding contracts under 21 U.S.C nearly 40 name. Cell culture growth and biomanufacturing processes with Water for injection grade reagents upon an of! U.S. Food and Drug administration be inspected visually for particulate matter and discoloration prior to,! And information will be managed by Vivli and Pfizer issued on September 26, 2014 fluid and electrolyte.... Container is a Type I borosilicate glass and meets the requirements of the U.S. Food and administration... Researchers for access to Pfizer clinical data and information will be managed Vivli. Agencies from awarding contracts in this Warning Letter 320-14-15 was issued on September 26, 2014 176.... Did not recognize this problem approximately isotonic solution 3 ) of your operators did not recognize this problem interruptions your! Review Panels decision is considered final and binding Pty, Limited, FEI 3001174929: Warning may., packaging materials and finished products 's close on Wednesday use of the glass.

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