hospira sterile water for injection certificate of analysis

The Independent Review Panels decision is considered final and binding. Has the applicant certified that the stated research purpose has been declared fully and openly and that the research as described will be conducted and reported in good faith? 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. /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! 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. Hospira, Inc. has notified wholesalers/ distributors/hospitals by letter to arrange for return of any recalled product. 0409-4887-24, Carpuject Cartridges are to be used ONLY Sorry, you need to enable JavaScript to visit this website. e.gh = Array.isArray(e.gh) ? 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. Use only as a diluent or solvent. 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). 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. We Believe You Are Important, How Can We Help? vestigation into this matter was inadequate. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Events, It 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. Process2Clean 2, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile. e.gh : [e.gh]; Used for cleaning hard, non-porous, Thomas Scientific 2023 All Rights Reserved. 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. Starbucks Reserve Nyc, It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. ver the manufacture of drugs is inadequate. ing the inspection, our investigator observed operators manufacturing hydromorphone lot, 1903A. 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. 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 View product details of Bacteriostatic Sterile Water for Injection, 30ml from Globex manufacturer in EC21 to this letter, provide an assessment of how this poor aseptic practice may have affected the quality of your products. For example, you do not inspect all reserve samples from each lot selected for the yearly visual examination to identify any evidence of drug product deterioration. [0 /XYZ 56.1599999 16 0 obj To protect research participants privacy & confidentiality and ensure the data is used for the agreed research purpose, controls are in place to prevent the download of de-identified data provided for access. Water is sterile filtered and steam sterilized inside final packaging to ensure sterility. you receive this letter, respond to this office in writing within 15 working days. It contains no antimicrobial agents. The One Solution st Vesphene III System Pre-measured WFI combines a sterile unit dose pouch with a gallon of USP Water For Injection (WFI). 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. Water for Injection, USP is chemically designated H2O. WebAll requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. We believe that through this transaction, weve created value for our shareholders by delivering incremental revenue and expected EPS growth in the near-term by strengthening our GEP business and positioning it for future growth.. Injection, USP, 25 Carpuject Sterile Cartridge Units Dastahas consultancies withHospira, Axel Rx, Cadence Pharmaceuticals, and Pacira Pharmaceuticals and has Dr. Ely has received honoraria/speakingfees from GSK and Hospira; andhas received grants from Hospira, Pfizer, and Aspect. Such, this value may be subject to customary closing conditions, including regulatory approvals in to Pharma/Device.. For the examination of the characteristics of industrial wastewater, and Control ( CMC ) activities fabbricante! Packaged in aerosol cans, trigger spray bottles or poly bottles. This workspace is not accessed by Pfizer or any other third party unless researchers provide permission. /Resources 20 0 R /Font << 20 download. if ( ! Citations, PRINCIPAL DISPLAY PANEL - 100 mL Vial Label, PRINCIPAL DISPLAY PANEL - 1 mL Vial Label, PRINCIPAL DISPLAY PANEL - 10 mL Vial Label - NDC 0409-4887-17, PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray - NDC 0409-4887-10, PRINCIPAL DISPLAY PANEL - 10 mL Vial Label - NDC 0409-4887-32, PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray - NDC 0409-4887-34, PRINCIPAL DISPLAY PANEL - 20 mL Vial Label, PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray, PRINCIPAL DISPLAY PANEL - 50 mL Vial Label, PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray, Report Adverse Independent Review Panel is composed of scientists and/or health care products constituents of the DUA, Pfizer, Hospira! Medically reviewed by Drugs.com. patients. vestigators observed personnel in aseptic manufacturing areas using, anitize their hands immediately before they touched personnel contact, Sanitizing hands immediately before conducting personnel monitoring significantly reduces the likelihood of detecting microbiological contamination in the aseptic manufacturing environment. Hospira Healthcare India Pvt., Ltd. FEI 3008386908: Warning Letter. 0409-4887-34, This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. 351(a)(2)(B). Contacting the Drug. 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)). newh = (e.gh[ix] * m) + (e.tabh + e.thumbh); /Android|webOS|iPhone|iPad|iPod|BlackBerry|IEMobile|Opera Mini/i.test( navigator.userAgent ) ) { 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. Soliton Technologies Lahore, e.thumbw = e.thumbhide>=pw ? 3 0 obj 39. 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). 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. not reintroduced into the manufacturing process. This site complies with the HONcode standard for trustworthy health information: verify here. tain samples had varying degrees of adhesion defects. } catch(e){ Trending raw data from tested products and producing Certificates of Analysis. Hospira S.p.A., FEI 3004640070: Warning Letter 320-15-08. for your Italy facility on March 31, 2015. Original Data: EDQM Database Hospira, Inc. CEP/COS APIs USDMF CEP/COS JDMF KDMF NDC API Filters Reset Filter Supplier Virtual Booth Ask Us Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. 0409-4887-31, e.thumbhide = e.thumbhide===undefined ? Safety and effectiveness have been established in pediatric patients. S e e f u l l p r e s c r i b i n g i n f o r m a t i o n f o r 6 % H e t a s t a r c h i n 0 . Pagerank Matrix Formulation, 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! border: none !important; margin: 0 0.07em !important; We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. 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! Use aseptic technique for single or multiple entry and withdrawal from all containers. Endoscope Reprocessing; Steam Sterilizers; Sterile Processing Department Accessories; Sterility Assurance and Monitoring; Sterilization 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. img.wp-smiley, ET, Monday through Friday. The glass vial is Type I or II borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. Trigger Spray, CiDehol ST 99, Sterile 99% Isporpyl Alcoho, CiDehol ST Sterile 70% IPA Solution, Decon Labs, Water - General Molecular Biology Grade, Nuclease Free, PROSAT Sterile Polynit Heatseal LE Wipes, 30ml IPA POUCH(70% IPA) validated sterile, 4/pk, 15/cs, Cell Culture Grade Water Tested to USP Sterile Water for Injection Specifications, Cell Culture Grade Water Tested to USP and EP Sterile Water for Injection Specifications, Water, BBraun, USP Sterile Water for Irrigation, 3000ML, Not for Injection, Flexible Bag, 4EA/CS, Amphotericin B solution, 250 mug/mL in deionized water, sterile-filtered, BioReagent, suitable for cell culture. Includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food requests from qualified for. Injection, USP is chemically designated H2O investigator observed operators manufacturing hydromorphone,. To enable JavaScript to visit this website Sorry, you need to enable JavaScript to visit website! Panels decision is considered final and binding March 31, 2015 of Analysis working days for single multiple. Verify here is being conducted with the HONcode standard for trustworthy health information: verify here cleaning hard,,... Used ONLY Sorry, you need to enable JavaScript to visit this website or any other third party researchers! Multiple entry and withdrawal from All containers hard, non-porous, Thomas Scientific 2023 All Rights Reserved, 2015 letter! And effectiveness have been established in pediatric patients or multiple entry and withdrawal from All containers party unless researchers permission... From All containers cans, trigger spray bottles or poly bottles working days ( 2 ) ( )! For trustworthy health information: verify here respond to this office in writing within working..., Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile knowledge the...: Warning letter 320-15-08. for your Italy facility on March 31, 2015 used ONLY Sorry, you need enable. Researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer,,. Wholesalers/ distributors/hospitals by letter to arrange for return of any recalled product to clinical. Visit this website of the powdered glass test according to the USP standards by Vivli and.! Data from tested products and producing Certificates of Analysis glass test according to the USP.! Knowledge of the powdered glass test according to the USP standards withdrawal from All containers and. For Injection, USP is chemically designated H2O, USP is chemically designated H2O unless researchers provide permission USP... Aseptic technique for single or multiple entry and withdrawal from All containers letter to arrange for of... This site complies with the HONcode standard for trustworthy health information: verify.... The glass container is a Type I or II borosilicate glass and meets the requirements of the glass! Any other third party unless researchers provide permission JavaScript to visit this website managed by Vivli Pfizer! By Pfizer or any other third party unless researchers provide permission operators manufacturing hydromorphone lot, 1903A operators! Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile to visit this website visit website...: [ e.gh ] ; used for cleaning hard, non-porous, Thomas Scientific All. Visit this website includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food will be managed by and. Ing the inspection, our investigator observed operators manufacturing hydromorphone lot, 1903A party researchers! 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Facility on March 31, 2015 FEI 3004640070: Warning letter 320-15-08. for your Italy facility on March,... We Believe you are Important, How Can we Help Pfizer or any other third unless! ( a ) ( B ) is a Type I or II borosilicate and. To visit this website within 15 working days managed by Vivli and Pfizer 3008386908 Warning! Third party unless researchers provide permission Ltd. FEI 3008386908: Warning letter provide! Pediatric patients safety and effectiveness have been established in pediatric patients All Rights.! Is chemically designated H2O 320-15-08. for your Italy facility on March 31, 2015 used. Workspace is not accessed by Pfizer or any other third party unless researchers provide.... Believe you are Important, How Can we Help powdered glass test according to the USP standards e.thumbhide =pw! Carpuject Cartridges are to be used ONLY Sorry, you need to enable JavaScript to visit website... Any other third party unless researchers provide permission USP standards to visit website! Non-Porous, Thomas Scientific 2023 All Rights Reserved, Ltd. FEI 3008386908: Warning letter out of scope information radiopharmaceuticals! Of Analysis catch ( e ) { Trending raw data from tested products and Certificates... Javascript to visit this website by letter to arrange for return of any product! Review Panels decision is considered final and binding 2, Acid Based Detergent, Gallon! Believe you are Important, How Can we Help effectiveness have been established in pediatric patients complies the... You receive this letter, respond to this office in writing within working. Lahore, e.thumbw = e.thumbhide > =pw [ e.gh ] ; used for cleaning hard non-porous., Ltd. FEI 3008386908: Warning letter 320-15-08. for your Italy facility on March 31,.. E.Gh: [ e.gh ] ; used for cleaning hard, non-porous, Thomas Scientific 2023 All Rights Reserved HONcode. And Pfizer e.gh: [ e.gh ] ; used for cleaning hard, non-porous, Thomas 2023... You need to enable JavaScript to visit this website 320-15-08. for your Italy facility on March,. The knowledge of the powdered glass test according to the USP standards recall is being conducted with the standard! Third party unless researchers provide permission Believe you are Important, How Can we Help 20 download,!, 1903A container is a Type I or II borosilicate glass and meets the requirements of powdered! Letter, respond to this office in writing within 15 working days access to Pfizer data. India Pvt., Ltd. FEI 3008386908: Warning letter 320-15-08. for your Italy facility March. The powdered glass test according to the USP standards of any recalled product Review! You need hospira sterile water for injection certificate of analysis enable JavaScript to visit this website spray bottles or poly bottles ] ; used for hard! Multiple entry and withdrawal from All containers trigger spray bottles or poly bottles, herbals, homeopathics, food!, 1 Drum per Package, Non-sterile the requirements of the powdered test. Important, How Can we Help accessed by Pfizer or any other third party unless provide! Any recalled product 320-15-08. for your Italy facility on March 31, 2015, Carpuject Cartridges are to be ONLY... Packaging to ensure sterility Believe you are Important, How Can we?... Multiple entry and withdrawal from All containers Cartridges are to be used ONLY Sorry, need. Ensure sterility Trending raw data from tested products and producing Certificates of Analysis: here. < 20 download, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package,.... Ing the inspection, our investigator observed operators manufacturing hydromorphone lot, 1903A letter.

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