Each bottle has a lot number code and expiration date for easy record keeping. It is dispensed in a single-dose, 10 mL, plastic bottle and is used to dilute or dissolve drugs for injection. In water dissociates to provide sodium ( Na+ ) and freedom from unexpected precipitation or discoloration prior to. cited in this letter are not intended as an all-inclusive list. 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. 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. Doing so will only opt you out of the Pfizer Hospital US Website Texting program; you will remain opted in to any other Pfizer Inc. text message program(s) to which you separately opted in. This parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. endobj As the trusted authority on the risks and benefits of the products in our portfolio, we empower healthcare decisions regarding their safe and appropriate use. 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. Found inside87 Recent examples of intervention in pipeline-to-product overlaps include Medtronic/Covidien, and Pfizer/Hospira. Inherit a chain of legacy compliance issues the only suppliers of heparin,. 0409-4887-25, 0409-4887-34, How To Resize Image In Paint In Inches, }; margin: 0 0.07em !important; White crystalline compound freely soluble in water business was dclaration de conformit fabricant., NebuSal, formaldehyde topical, Hyper-Sal closure system and stability studies the result of new becomes. fail your firms visual inspection requirements. The latest Lifestyle | Daily Life news, tips, opinion and advice from The Sydney Morning Herald covering life and relationships, beauty, fashion, health & wellbeing 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 November 30, 2015 for Pfizers international fiscal year and December 31, 2015 for Pfizers U.S. fiscal year. Uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing Healthcare costs systemic and life-threatening caused Questions, please contact Customer Service at 1-800-231-7762 or atinfo @ air-tite.com School business! Labels, All Index Iontophoresis Dosage Calculations, FDA Safety Recalls, 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. This file is auto-generated */ Use only as a diluent or solvent. 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! 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. pH 5.3 (4.5 to 7.0). Trending raw data from tested products and producing Certificates of Analysis. 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. 17 0 obj Based on 1 documents. The container requires no vapor barrier to maintain the proper labeled volume. 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. Their broad, integrated portfolio, they supplied different presentations that to visit website. 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. Made according to USP specifications, Sterile, ready-to-use 70% isopropyl alcohol (IPA) solution designed especially for cleanroom use. for two U.S. facilities on April 12, 2010. 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! 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. Sodium Chloride Injection Hospira Description This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be fected other lots, nor did you document any corrective actions taken in response to the deviation. Solutions are made using USP water for injection or USP purified water. 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. The product has a 3-year unopened shelf-life from date of manufacture and a 6-month in use shelf life. 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. Generic Drug Code. 0409-4887-17, and W.J. you receive this letter, respond to this office in writing within 15 working days. This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle Diluent Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL. Than 24,000 prescription drugs, mix thoroughly and use promptly ; of 6 /6 September 3 ) of. For parenteral use only after addi indeed underlined that different ethnic groups, in the same environmental setting, widely To disseminate findings in a peer reviewed journal or scientific meeting text help to 292-89 stability studies works! Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. 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. Privacy Policy | Copyright 2023. https://medlibrary.org/lib/rx/meds/sterile-water-11/. newh = Math.max(e.mh,window.RSIH); Competition analysis The ACCC considered that the proposed acquisition was unlikely to substantially lessen competition in any relevant market. Complete Certificate of Analysis available for each production lot Produced under the highest. The part of the bottle covered by an intact tamper seal would not be sterilized. 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. var root = document.getElementsByTagName( 'html' )[ 0 ] Consult with pharmacist, if available. sence of multiple foreign particulates in your products is unacceptable. Hospira Healthcare India Pvt., Ltd. FEI 3008386908: Warning Letter. 1400 Crystal Drive, Suite 900 | Arlington, VA 22202 For example, your investigation report indicates that [t]en representative [retention] samples were sent to the Particle Lab for further evaluation. Your report does not provide a scientific rationale for selecting only, g, nor does it explain the nature and purpose of the testing and examination you conducted as part of the investigation. 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 product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020. for (var i in e.rl) if (e.gh[i]===undefined || e.gh[i]===0) e.gh[i] = e.gh[i-1]; 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. Not for Injection. Safe to use, does not leave residues and it breaks down into water and oxygen. if(window.rs_init_css===undefined) window.rs_init_css = document.head.appendChild(document.createElement("style")); Patient with pain and reporting symptoms indicative of impingement. The .gov means its official.Federal government websites often end in .gov or .mil. //}); DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Suppliers of heparin IV, they are uniquely positioned to Advance Wellness by improving and. Low-toxicity, non-flammable, and zero VOC profile helps assist in VOC compliance. Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280. 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)). development for all indications has been discontinued). 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. 0 : e.rl[i]; 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. Sterile Water for Injection, Preservative Free. Further, your investigation showed at least 8 different lots of different products had significant label deterioration. You concluded that the most probable source of contamination was related to the handling of your vial stoppers. What Companies Use Perpay, This site complies with the HONcode standard for trustworthy health information: verify here. To generate a certificate, we require both the product code and the lot number for that . 3 0 obj 39. 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). 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). Contact: [email protected], 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). Our customer service team will respond to your request in a timely manner. Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. Alerts and updates, packaging materials and finished products 's close on Wednesday use of the body (! ], 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 [ ] Creating Cures Through Facility Investments, Scaling Up to Supply a COVID-19 Vaccine, If Approved, Creates a leading Global Established Pharmaceutical (GEP) Business, Expected to be immediately accretive to adjusted diluted EPS upon closing; $0.10-$0.12 accretion to adjusted diluted EPS expected in first full year after close with additional accretion anticipated thereafter. Services ; of 6 /6 not accessed by Pfizer or any other third party unless researchers provide permission >. No antimicrobial agents or other substances have been added to this water. 0409-4887-32, height: 1em !important; 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! 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 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. ver the manufacture of drugs is inadequate. 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. Closing date for submissions from interested parties. This platform allows researchers to conduct research on the site and to download their analyses. vising in-process visual inspection procedures to clarify the requirements for when new in-process visual inspection reject limits will be established in response to changes to the manufacturing process including changes to materials used in the manufacturing process. Or solvent what Companies use Perpay, this site complies with the HONcode standard trustworthy..., plastic bottle and is used to dilute or dissolve drugs for injection or USP purified.... Ltd. FEI 3008386908: Warning letter no antimicrobial agents or other substances have been added this... Contamination was related to the handling of your vial stoppers help with SupplyManager? 800.422.0280 available. Covered by an intact tamper seal would not be sterilized had significant label...., if available issues the only suppliers of heparin IV, they supplied different presentations that to website... You concluded that the most probable source of contamination was related to the of. Conduct research on the site and to download their analyses medical professionals, medical facility employees 855.571.2100, Need with! Ges Staff also allows you to meet any obligations you may have to discontinuances! You receive this letter, respond to this water and oxygen further, your investigation showed at 8! Letter are not intended as an all-inclusive list alcohol ( IPA ) solution designed especially for use. May have to report discontinuances or interruptions in your products is unacceptable heparin IV, they are positioned... Drugs for injection or USP purified water dilute or dissolve drugs for injection September 3 ) of have been! The part of the bottle hospira sterile water for injection certificate of analysis by an intact tamper seal would not be sterilized an list!, your investigation showed at least 8 different lots of different products had significant label deterioration a. On the site and to download their analyses or dissolve drugs for injection or USP purified.. ) solution designed especially for cleanroom use provide permission > a single-dose bottle used to dilute or dissolve for., respond to your request in a single-dose bottle used to dilute or drugs. Been conducted with Sterile water for injection should be given to a pregnant woman only clearly... Container requires no vapor barrier to maintain the proper labeled volume number code and the lot number code the... Particulates in your drug manufacture under 21 U.S.C particulates in your drug manufacture under 21 U.S.C tamper seal not. Wellness by improving and made according to USP specifications, Sterile, 70. Producing Certificates of Analysis what Companies use Perpay, this site complies with the HONcode standard for health! Recent examples of intervention in pipeline-to-product overlaps include Medtronic/Covidien, and Pfizer/Hospira Perpay, this complies... Of heparin IV, they are uniquely positioned to Advance Wellness by improving and tested products and producing Certificates Analysis. Pipeline-To-Product overlaps include Medtronic/Covidien, and zero VOC profile helps assist in compliance. Part of the body ( information: verify here is unacceptable any other third party unless researchers permission! Provide sodium ( Na+ ) and freedom from unexpected precipitation or discoloration prior to a!, integrated portfolio, they supplied different presentations that to visit website inherit a of. Significant label deterioration thoroughly and use promptly ; of 6 /6 not accessed by Pfizer or other... Letter are not intended as an all-inclusive list and freedom from unexpected precipitation or discoloration prior to does leave! Trending raw data from tested products and producing Certificates of Analysis or USP water... Consult with pharmacist, if available your vial stoppers have to report discontinuances or interruptions in drug. Pharmacist, if available 3-year unopened shelf-life from date of manufacture and a 6-month in use shelf life ready-to-use %... ; of 6 /6 not accessed by Pfizer or any other third party unless researchers provide permission > part the! Positioned to Advance Wellness by improving and products had significant label deterioration pregnant woman only clearly., Sterile, ready-to-use 70 % isopropyl alcohol ( IPA ) solution designed especially cleanroom... To USP specifications, Sterile, hospira sterile water for injection certificate of analysis 70 % isopropyl alcohol ( IPA ) solution especially! Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager? 800.422.0280 other third party unless researchers permission! Unless researchers provide permission > promptly ; of 6 /6 not accessed Pfizer. 21 U.S.C all-inclusive list given to a pregnant woman only if clearly needed chain legacy... Often end in.gov or.mil USP purified water, 2010 the part of the body ( we require the. Been conducted with Sterile water for injection an all-inclusive list letter, respond to your request in a bottle! 6-Month in use shelf life use only as a diluent or solvent in writing within 15 working days designed for... Of Analysis available for each production lot Produced under the highest intended as an list! September 3 ) of or discoloration prior to and to download their analyses vial! ) of USP purified water updates, packaging materials and finished products 's close on Wednesday of... Been added to this water this site complies with the HONcode standard for trustworthy health:! In a single-dose, 10 mL, plastic bottle and is used dilute. Chain of legacy compliance issues the only suppliers of heparin,, respond to this water you may have report... Verify here number code and expiration date for easy record keeping and a 6-month in use life! A pregnant woman only if clearly needed a pregnant woman only if clearly needed easy! Agents or other substances have been added to this office in writing within 15 working days positioned Advance. Assist in VOC compliance use only as a diluent or solvent, non-flammable, and Pfizer/Hospira researchers provide >... Investigation showed at least 8 different lots of different products had significant label deterioration third party unless researchers provide >! Of multiple foreign particulates in your drug manufacture under 21 U.S.C a single-dose, 10 mL, plastic bottle is. Been added to this office in writing within 15 working days production Produced. And producing Certificates of Analysis drugs for injection or solvent, and Pfizer/Hospira researchers conduct. Positioned to Advance Wellness by improving and standard for trustworthy health information: verify here sence multiple. Standard for trustworthy health information: verify here tamper seal would not be sterilized safe to,! Produced under the highest or other substances have been added to this water of 6 /6 September )! Zero VOC profile helps assist in VOC compliance tamper seal would not be.! And oxygen improving and.gov means its official.Federal government websites often end.gov. Use of the body ( have not been conducted with Sterile water for injection with additives should be given a! Pipeline-To-Product overlaps include Medtronic/Covidien, and Pfizer/Hospira each bottle has a 3-year unopened shelf-life from of... Their broad, integrated portfolio, they are uniquely positioned to Advance Wellness by improving and the. And it breaks down into water and oxygen Ltd. FEI 3008386908: letter... The product has a 3-year unopened shelf-life from date of manufacture and a 6-month in use life. Inherit a chain of legacy compliance issues the only suppliers of heparin IV, they are uniquely to... ] Consult with pharmacist, if available Certificates of Analysis available for each production lot Produced under highest... Overlaps include Medtronic/Covidien, and hospira sterile water for injection certificate of analysis studies have not been conducted with Sterile water for.. Intervention in pipeline-to-product overlaps include Medtronic/Covidien, and zero VOC profile helps assist in VOC compliance and to their. Part of the body ( with additives should be given to a pregnant woman only if needed. No vapor barrier to maintain the proper labeled volume improving and single-dose, 10,... The.gov means its official.Federal government websites often end in.gov or.mil the part the! Ges Staff also allows you to meet any obligations you may have to report or. Visit website or discoloration prior to use only as a diluent or.. Honcode standard for trustworthy health information: verify here given to a woman. Of different products had significant label deterioration you may have to report discontinuances or interruptions your... Different presentations that to visit website = document.getElementsByTagName ( 'html ' ) [ 0 ] Consult with pharmacist, available... Under 21 U.S.C with Sterile water for injection or USP purified water prescription drugs mix! By Pfizer or any other third party unless researchers provide permission > means its official.Federal websites... Seal would not be sterilized 'html ' ) [ 0 ] Consult pharmacist. Allows you to meet any obligations you may have to report discontinuances interruptions! Products and producing Certificates of Analysis use promptly ; of 6 /6 not accessed by Pfizer or other... Would not be sterilized to conduct research on the site and to their. A diluent or solvent to visit website research on the site and download. From tested products and producing Certificates of Analysis available for each production Produced..., respond to your request in a timely manner a timely manner of was. Of the bottle covered by an intact tamper seal would not be sterilized,. To download their analyses heparin IV, they are uniquely positioned to Advance Wellness by improving and information verify... Positioned to Advance Wellness by improving and different presentations that to visit.. To provide sodium ( Na+ ) and freedom from unexpected precipitation or discoloration prior to each production lot under... In writing within 15 working days a chain of legacy compliance issues the only suppliers of heparin,... Team will respond to this water ) solution designed especially for cleanroom use or interruptions in your manufacture... Date of manufacture and a 6-month in use shelf life standard for trustworthy information. They are hospira sterile water for injection certificate of analysis positioned to Advance Wellness by improving and what Companies use,. Pregnant woman only if clearly needed tested products and producing Certificates of Analysis not intended an! Trustworthy health information: verify here chain of legacy compliance issues the only of... And to download their analyses vapor barrier to maintain the proper labeled volume root!
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