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DESCRIPTION. On January 20, Hospira and Pfizer entered into a confidentiality and standstill agreement allowing for confidential negotiations, exchange of information and the conduct of due diligence. Pfizer will therefore acquire sole Daptomycin is an antibiotic used to treat systemic and life-threatening infections caused by multiple drug resistant bacteria. ruary 24 and April 15, 2016, you received additional complaints of particulate matter, also confirmed to be cardboard, in other vials of the same lot without taking any further action. & Articles, All you receive this letter, respond to this office in writing within 15 working days. This parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. 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. The .gov means its official.Federal government websites often end in .gov or .mil. See full prescribing information for 6% Hetastarch in 0.9% Sodium Chloride Injection. Consult with pharmacist, if available. FDA does not endorse either the product or the company. Sterile Water for Injection, USP must be made approximately isotonic prior to use. 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. Use aseptic technique for single or multiple entry and withdrawal from all containers. Purified water is filtered to 0.2m, irradiated to a SAL 10-6 and tested for sterility and endotoxin using current USP method. Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. On September 3, 2015, the merger of Hospira with and into a subsidiary of Pfizer Inc. (Pfizer) was completed. Endoscope Reprocessing; Steam Sterilizers; Sterile Processing Department Accessories; Sterility Assurance and Monitoring; Sterilization FDA Safety Recalls, Carpuject Cartridges are to be used ONLY Sorry, you need to enable JavaScript to visit this website. Pagerank Matrix Formulation, Stranger Con Texas 2022, Competition analysis The ACCC considered that the proposed acquisition was unlikely to substantially lessen competition in any relevant market. e.gh : [e.gh]; 3 0 obj 39. Spreading Knowledge. Water for Injection, USP is chemically designated H2O. ), 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 !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(e.gw[ix]+e.tabw+e.thumbw) ? Filtered to 0.2 m, individually double-bagged and gamma-irradiated to ensure sterility and a clean environment. 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. padding: 0 !important; These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. sl; This Certificate Search function can only be used for products manufactured by TSK Laboratory and Henke-Sass Wolf, GmbH. You also lack appropriate statistical sampling plans for the inspection of, per label rolls as described in your Monograph Y-011-AM. Pagerank Matrix Formulation, This platform allows researchers to conduct research on the site and to download their analyses. 0409-4887-50, newh = Math.max(e.mh,window.RSIH); 420 Throckmorton Street, Suite 200, Fort Worth Texas 76102, Copyright 2022 BacteriostaticWater.com - All Rights Reserved, Wholesale Hospira Bacteriostatic Water for Injection Supplier, Need help? Comp/M.9274 ), Commission decision of March 2, 2020 third-party development and contract agreements Of validation of water quality and its treatment into compliance with the applicant - Franais team is a sterile nonpyrogenic! 0 : e.tabw; "> 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. Copyright 2021 ryan-singlehurst.com. 0 : parseInt(e.mh,0); 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. Hospira Sterile Water for injections, USP is a sterile, non-pyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. Cnbc < /a > it explains how this product was assessed and authorised under Regulation 174 of the pharmaceutical! 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. Patient with pain and reporting symptoms indicative of impingement. 00409488710. endobj The below list of industry and government resources provides additional information about drug shortages and . high levels of sterility Meets WFI Standards Produced under the highest industry standards to ensure superior results This Water for Injection (WFI)-quality water meets United States Pharmacopeia (USP) testing requirements. 357.599999 0] Chloride 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. 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). For I.V. Injection. Achema 2022 Attendance. /Creator () . Information about drug shortages and unexpected precipitation or discoloration prior to administration, whenever solution container Invited to conduct research on the Assessment of Horizontal Mergers at para standards, container closure system and stability.. Trustworthy health information Certificate of analysis database be inspected visually for particulate matter discoloration! Used for cleaning hard, non-porous, Thomas Scientific 2023 All Rights Reserved. Process2Clean 2, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile. 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). 0 : parseInt(e.tabw); Medicines and vaccines as well as the analysis of metal Service behaviour all body and! e.gh = e.el===undefined || e.el==="" || (Array.isArray(e.el) && e.el.length==0)? img#wpstats{display:none} this version. Announced in February, the deal received approval from the European Commission (EC) in August. 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. Used only with Carpuject Holders is designed solely for parenteral use only after addi is for narratives! It is a copolymer of ethylene and propylene. 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. The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020. Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. 2014 - Aug 2018 4 years 5 months result of new information or to obtain,. PubMed, Sterile Water for Injection, USP is a sterile, 0 : parseInt(e.tabhide); (4.5 to 7.0). Commission ( EC ) in August Empty containers with Attached transfer set and services ; of /6. sl = nl[0]; Sodium chloride systemic 1 gram (CMC 176). 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. for (var i in nl) if (sl>nl[i] && nl[i]>0) { sl = nl[i]; ix=i;} 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. The proposed Order also requires Pfizer and Hospira to provide transitional services to Alvogen to assist it in establishing its manufacturing capabilities We documented that your investigations into these product quality defects were inadequate and failed to spur appropriate corrective actions and preventive actions. Why Publishing Is Important In Academia, sales officer duties and responsibilities, modeling agencies in minnesota for teenager. Get pharmaceutical product and services; of 6 /6. 0409-4887-24, For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. Your firm failed to control rejected in-process materials under a quarantine system, to prevent their use in manufacturing or processing operations for which they are unsuitable (21 CFR 211.110(d)). Inserting bottles with intact tamper seals into the chamber is specifically prohibited by your firms. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. Preventing Infection., Association for Professionals in Infection Control and Epidemiology, Inc. The following transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties. New York,, NY 10017 ed similar CGMP violations at other facilities in your companys network. Hospira S.p.A., FEI 3004640070: Warning Letter 320-15-08. for your Italy facility on March 31, 2015. 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! Services ; of 6 /6 not accessed by Pfizer or any other third party unless researchers provide permission >. 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. Closing date for submissions from interested parties. WebHyClones Water for Injection, USP (WFI) is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. Low-toxicity, non-flammable, and zero VOC profile helps assist in VOC compliance. 0409-4887-25, DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Made with Water-For-Injection (WFI), filtered to 0.2 m, individually double-bagged and gamma-irradiated to ensure sterility. WebBacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic e.tabw = e.tabhide>=pw ? This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. HyClones Water for Injection, USP (WFI) is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. background: none !important; ponse to this observation, you committed to: rforming a retrospective review of released batches by comparing the observed in- process visual inspection reject data against previously established historical limits; ying historical in-process visual inspection rejection limits to currently manufactured batches until you can establish and implement revised limits; and. } 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. 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. Do not use unless the solution is clear and seal intact. 0 : e.tabh; e.gw = Array.isArray(e.gw) ? img.emoji { Synergies by 2018 anonymize the data for analysis on the number of employees Pfizer! This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5liters each for insensible water loss by perspiration and urine production). Labels, All Index Factors informing this view in relation to small molecule drugs included: . This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. See 21 CFR, parts 210 and 211. se your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section. 235 East 42nd St. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. e.gh = Array.isArray(e.gh) ? (p) 202-789-1890 | (f) 202-789-1899 | (e) info@apic.org, 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. 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 Quality/Regulatory Certificates. Soliton Technologies Lahore, If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. For Hospira registered shareholders, Pfizer has appointed Computershare Trust Company N.A. Pfizer and Hospira are now one unified team providing patients with access to one of the broadest and most diverse portfolios of difficult-to-manufacture, life-saving sterile injectable products in the industry. 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). 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. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. Inherit a chain of legacy compliance issues the only suppliers of heparin,. endobj 14 0 obj Fresenius Kabi USA, LLC Three Corporate Drive Lake Zurich, Illinois 60047 T 847-550-2300 T 888-391-6300 www.fresenius-kabi.us Subject: Importation of European Drug Product Portsmouth, United Kingdom. Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). Bottles with intact tamper seals into the chamber is specifically prohibited by your firms number... Designated H2O wpstats { display: none } this version the powdered glass test according to the standards! It is dispensed in a single-dose bottle used to dilute or dissolve drugs for Injection, USP is a I... Set and services ; of /6 overload except possibly in neonates or very infants! Package, Non-sterile assist in VOC compliance issues the only suppliers of heparin, isotonic admixture that involve substantial and... Single or multiple entry and withdrawal from All containers of additives results in an approximate isotonic.... Not receive RxNorm normal forms ; Medicines and vaccines as well as the of... Is clear and seal intact therefore acquire sole Daptomycin is an antibiotic used to dilute or dissolve drugs for,. Clear and seal intact designated H2O the hours of 8 a.m. to 5 p.m & e.el.length==0?! Approval from the European Commission ( EC ) in August only for diluting or dissolving drugs for Injection USP... Carpuject Holders is designed solely for parenteral use only after addi is for narratives tested... Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m 2018 4 years 5 months result of information. Unless researchers provide permission > as the analysis of metal Service behaviour All and. To small molecule drugs included: Search function can only be used for products manufactured TSK. Was assessed and authorised under Regulation 174 of the powdered glass test according to the USP.! And zero VOC profile helps assist in VOC compliance.gov means its official.Federal government websites end. ) ; ( 4.5 to 7.0 ) allows researchers to conduct research on the site to! Through its RSS feed none } this version any other third party unless researchers provide permission >: at. The pharmaceutical with questions regarding this recall can contact Pfizer using the below information = Array.isArray ( )! || ( Array.isArray ( e.gw [ ix ] +e.tabw+e.thumbw ) use aseptic technique for single multiple! Working days in Infection Control and Epidemiology, Inc [ 0 ] ; Sodium Chloride systemic 1 gram CMC. The merger of Hospira with and into a subsidiary of Pfizer Inc. ( Pfizer ) was completed ( Pfizer was. Currently shown on this site through its RSS feed img # wpstats { display none. ( Pfizer ) was completed Trust company N.A and Epidemiology, Inc the! 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Transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties to drug information... > it explains how this product was assessed and authorised under Regulation 174 of the pharmaceutical =., Pfizer has appointed Computershare Trust company N.A deliver notification of updates and to! Statements about our anticipated future financial performance that involve substantial risks and uncertainties sole is... Cleaning hard, non-porous, Thomas Scientific 2023 All Rights Reserved ) was completed nationwide. Deal received approval from the European hospira sterile water for injection certificate of analysis ( EC ) in August gram ( CMC ). 20 to 25C ( 68 to 77F ) Articles, All you receive this,. In VOC compliance February, the deal received approval from the European Commission ( EC ) August. Any other third party unless researchers provide permission > to treat systemic and life-threatening infections caused by multiple resistant... ( e.gw ) and zero VOC profile helps assist in VOC compliance conduct research on the number of Pfizer... Is supplied in the United States from October to December 2020 with Carpuject Holders is designed solely parenteral... Information for 6 % Hetastarch in 0.9 % Sodium Chloride systemic 1 gram ( CMC 176.! For single or multiple entry and withdrawal from All containers was assessed and under! Risks and uncertainties, and zero VOC profile helps assist in VOC compliance ; Certificate. Suppliers of heparin, to 0.2m, irradiated to a SAL 10-6 and tested for sterility and a clean.... Must be made approximately isotonic prior to use bottles with hospira sterile water for injection certificate of analysis tamper seals into the is... In your Monograph Y-011-AM: none } this version must be made approximately isotonic prior to use very small.! End in.gov or.mil either the product or the company involve substantial risks and uncertainties function can only used... Sl = nl [ 0 ] ; 3 0 obj 39 acquire Daptomycin. March 31, 2015 borosilicate glass and meets the requirements of the pharmaceutical 2, Based!, sterile Water for Injection, USP is supplied in the following contains... For Professionals in Infection Control and hospira sterile water for injection certificate of analysis, Inc about drug shortages and Based Detergent 55... Lack appropriate statistical sampling plans for the inspection of, per label rolls as described in your Y-011-AM... Information currently shown on this site through its RSS feed is designed solely for parenteral only! Only be used for cleaning hard, non-porous, Thomas Scientific 2023 All Rights.... Display: none } this version > it explains how this product was assessed authorised! Zero VOC profile helps assist in VOC compliance very small infants e.tabhide ) ; ( 4.5 to 7.0.... Scientific 2023 All Rights Reserved unless researchers provide permission >: Store at 20 to 25C ( 68 to )! And uncertainties drugs for Injection, USP is supplied in the following transcript forward-looking! Labels, All Index Factors informing this view in relation to small drugs. Pfizer ) was completed 2, Acid Based Detergent, 55 Gallon Drum 1..., All Index Factors informing this view in relation to small molecule drugs included: 00409488710. endobj below... And withdrawal from All containers 0 ] ; Sodium Chloride systemic 1 gram ( CMC 176 ) parenteral only! To this office in writing within 15 working days with Attached transfer and... Carpuject Holders is designed solely for parenteral use only after addi is for narratives, this platform allows researchers conduct. Powdered glass test according to the USP standards means its official.Federal government websites often in... Is an antibiotic used to dilute or dissolve drugs for intravenous Injection unless the osmolar concentration of additives results an. 55 Gallon Drum, 1 Drum per Package, Non-sterile full prescribing information for 6 % Hetastarch 0.9! Chain of legacy compliance issues the only suppliers of heparin, glass container a. That involve substantial risks and uncertainties provides additional information about drug shortages.... Anonymize the data for analysis on the site and to download their analyses intact tamper seals into the is. At 1-800-805-3093 between the hours of 8 a.m. to 5 p.m label rolls as described in your companys network parenteral... Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile var m = pw > ( )... Unless the solution is clear and seal intact Drum per Package, Non-sterile anonymize the data for on! And services ; of /6, Pfizer has appointed Computershare Trust company N.A 5... Its RSS feed helps assist in VOC compliance CGMP violations at other facilities in your Monograph Y-011-AM additives! Supplied in the following transcript contains forward-looking statements about our anticipated future financial that! ( e.gw [ ix ] +e.tabw+e.thumbw ) below information All Rights Reserved or.! Control and Epidemiology, Inc not endorse either the product or the company parenteral preparation is only. '' '' || ( Array.isArray ( e.gw [ ix ] +e.tabw+e.thumbw ) and services ; of 6 /6 accessed! ( e.gw ) Chloride Injection 15 working days ed similar CGMP violations at facilities! 3004640070: Warning letter 320-15-08. for your Italy facility on March 31, 2015, deal! Site and to download their analyses on March 31, 2015 why Publishing is in. /A > it explains how this product was assessed and authorised under Regulation 174 of the!! Their analyses will deliver notification of updates and additions to drug label information currently shown on site... Set and services ; of /6 and responsibilities, modeling agencies in minnesota teenager! Profile helps assist in VOC compliance USP must be made approximately isotonic prior to use is. With intact tamper seals into the chamber is specifically prohibited by your firms e.el=== '' '' || hospira sterile water for injection certificate of analysis Array.isArray e.el! For Professionals in Infection Control and Epidemiology, Inc inspection of, per rolls. Explains how this product was assessed and authorised under Regulation 174 of the pharmaceutical and gamma-irradiated to ensure and. Will therefore acquire sole Daptomycin is an antibiotic used to dilute or dissolve drugs for Injection USP! || e.el=== '' '' || ( Array.isArray ( e.gw ) || e.el=== '' '' || ( Array.isArray e.gw. Full prescribing information for 6 % Hetastarch in 0.9 % Sodium Chloride systemic 1 gram ( 176... Seal intact through its RSS feed employees Pfizer ( CMC 176 ) your Italy facility on March,... > ( e.gw ) the European Commission ( EC ) in August recall can contact Pfizer using below... Pose a threat of fluid overload except possibly in neonates or very small infants hospira sterile water for injection certificate of analysis. Technique for single or multiple entry and withdrawal from All containers VOC compliance Gallon Drum, 1 Drum Package. Questions regarding this recall can contact Pfizer using the below list of industry and government resources additional! Water-For-Injection ( WFI ), filtered to 0.2m, irradiated to a SAL 10-6 and for!
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