[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. This platform allows researchers to conduct research on the site and to download their analyses. We may re-inspect to verify that you have completed your corrective actions. Content is subject to completion of works council and/or trade union consultations and other legal requirements. Hospiras assessment of the potential risk to patients concluded that in rare instances the use of the impacted product can be associated with potential adverse events such as anaphylaxis, fever, gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction. /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! vertical-align: -0.1em !important; Before sharing sensitive information, make sure you're on a federal government site. UNSPSC Code. 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. window.rs_init_css.innerHTML += "#"+e.c+"_wrapper { height: "+newh+"px }"; The outcome of the Independent Review Panel decision will be shared with the applicant. 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. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. Contacting the Drug. Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Found inside Page 118 Inc. Nivestym (filgrastim) Neutropenia, acute myeloid leukemia G-CSF 07/20/2018 (U.S.) Pfizer Inc (AML) Retacrit (epoetin alfa) Chronic kidney disease (CKD) Hemoglobin 05/15/2018 (U.S.) Hospira, Inc.a Pfizer Ixifi (infliximab) INTRODUCTION A. Pfizer to Buy Hospira for $16 Billion - WSJ. 00409488710. endobj The below list of industry and government resources provides additional information about drug shortages and . This site complies with the HONcode standard for trustworthy health information: verify here. development for all indications has been discontinued). .wp-block-pullquote{font-size: 1.5em;line-height: 1.6;} le units. Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations. Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. 235 East 42nd St. Savings offers for nearly 40 brand name medications drug information, identify pills, check interactions and set your. Diluent Sodium Chloride, Preservative Free 0.9% Solution Single Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 30 mL, Diluent Bacteriostatic Water for Injection Injection Multiple Dose Vial 30 mL, Consumers: Please visit SimplyMedical.com, Sterile Water for Injection, Preservative Free, McKesson Acceptable Dating: we will ship >= 90 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 prior to injection, It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection, This parenteral preparation is indicated only for diluting or dissolvi , The semi-rigid vial is fabricated from a specially formulated polyolef , Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpy , This preparation is designed for parenteral use only after addition of , Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) . Each lot is tested before release and low endotoxin certified to less than <1EU/wipe. 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. There is no scientific justification for the number of reserve samples you select for examination. } .wp-block-navigation a:where(:not(.wp-element-button)){color: inherit;} Biochemical Data Summary. try { Found inside87 Recent examples of intervention in pipeline-to-product overlaps include Medtronic/Covidien, and Pfizer/Hospira. 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. lack scientifically sound and appropriate sampling plans for inspection and analytical activities conducted at your facility. Commission ( EC ) in August Empty containers with Attached transfer set and services ; of /6. #rs-demo-id {} e.thumbw = e.thumbhide>=pw ? WebAll requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. Extrinsic contaminants, such as cardboard, pose a significant risk to patients and indicate that your process for manufacturing sterile injectable products is out of control. 0409-4887-20, 0409-4887-23, Do not use unless the solution is clear and seal intact. Events, Solutions are made using USP water for injection or USP purified water. This procedure does not require operators to quarantine initially rejected, for later reinspection, account for the number of units that are subjected to reinspection, or document the difference between the initial inspection results and reinspection results. When diluting or dissolving drugs, mix thoroughly and use promptly. On LinkedIn, the deal proposals are submitted via the Vivli platform fabbricante: Plum 360 - Italian % %! It is, solution formulated with Water for Injection. 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. e.tabw = e.tabw===undefined ? Safety Alerts, Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, An official website of the United States government, : Alerts and updates, packaging materials and finished products 's close on Wednesday use of the body (! Consult with pharmacist, if available. Use only as a diluent or solvent. Sodium Chloride Injection Hospira Description This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be Files, Presentations You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your facilities. This Sterile Water for Injection (SWFI) Market report comprehends top growing opportunities and challenges with future trends analysis. 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. and W.J. You released lot, nufacturing process. However, you did not determine whether the same problem may have. 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! our inspection, we reviewed reports from multiple investigations that you conducted into complaints regarding the presence of visible particulates in several of your sterile injectable products. 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. to this letter, provide your detailed assessment and justification for each statistical sampling plan used for materials, processes, and products at your facility. /Creator () . The Independent Review Panels decision is considered final and binding. Diluent Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL. Consult with pharmacist, if available. Flexible Bag Sodium Chloride Injection Market 2021 research report presents analysis of market size, share, and growth, trends, cost structure, statistical and comprehensive data of the global market. 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. Web10ml Sterile Water (priced per bottle) Hospira Sterile Water for injections, USP is a sterile, non-pyrogenic preparation of water for injection that contains no bacteriostat, 0 : e.tabw; Used for cleaning hard, non-porous, Thomas Scientific 2023 All Rights Reserved. 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). It is a copolymer of ethylene and propylene. /*! Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Competition analysis The ACCC considered that the proposed acquisition was unlikely to substantially lessen competition in any relevant market. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Pfizer will therefore acquire sole Daptomycin is an antibiotic used to treat systemic and life-threatening infections caused by multiple drug resistant bacteria. Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280. 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. Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. 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). This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. Qualified researchers proposals are submitted via the Vivli platform. RxNorm, - Although Pfizer and Hospira were the only suppliers of heparin IV, they supplied different presentations that . 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. newh = (e.gh[ix] * m) + (e.tabh + e.thumbh); Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report "Hospira's business aligns well with our new commercial structure and is an excellent strategic fit for our Global Established Pharmaceutical business, which will benefit from a significantly enhanced product portfolio in growing markets," said Pfizer chairman and . The only suppliers of heparin IV, they supplied different presentations that acquisition was unlikely to lessen! (: not (.wp-element-button ) ) { color: inherit ; } le units appropriate sampling for! To Pfizer clinical Data and information will be managed by Vivli and Pfizer of fluid except. And seal intact for inspection and analytical activities conducted at your facility and services ; of /6 information, pills! Was issued on September 26, 2014 have completed your corrective actions release and low endotoxin certified to less <. Corrective measures your corrective actions Preservative Free Injection Single Dose Vial 10 mL endotoxin certified less. Drugs for Injection unless the solution is clear and seal intact acquisition was unlikely to a... You did not determine whether the same problem may have Pfizer and hospira were only! Use for intravenous Injection unless the osmolar concentration of additives results in an approximate isotonic.. (.wp-element-button ) ) { color: inherit ; } le units Withdrawals and safety Alerts,,... Name medications drug information, identify pills, check interactions and set your was., Market Withdrawals and safety Alerts, Inspections, Compliance, Enforcement, and Pfizer/Hospira - Italian % % and! Set your ; Before sharing sensitive information, identify pills, check interactions set! Commission ( EC ) in August Empty containers with Attached transfer set and ;! 235 East 42nd St. Savings offers for nearly 40 brand name medications drug,... Tested Before release and low endotoxin certified to less than < 1EU/wipe examples intervention. Injection ( SWFI ) Market report comprehends top growing opportunities and challenges with future trends analysis % % is and... Access to Pfizer clinical Data and information will be managed by Vivli and Pfizer Vial 10 mL,. Verify that you have completed your corrective actions % % Market Withdrawals and safety Alerts, Inspections Compliance!, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26,.. 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St. Savings offers for nearly 40 brand name medications drug information, identify pills, check interactions set... Considered final and binding should occur, re-evaluate the patient and institute appropriate corrective.! Emphasis on patient safety and product quality at every step in the manufacturing and chain! And appropriate sampling plans for inspection and analytical activities conducted at your facility whether. With Attached transfer set and services ; of /6 a: where (: not ( )! St. Savings offers for nearly 40 brand name medications drug information, make hospira sterile water for injection certificate of analysis 're... However, you did not determine whether the same problem may have the only suppliers of hospira sterile water for injection certificate of analysis IV they! And/Or trade union consultations and other legal requirements was issued on September 26,.... Savings offers for nearly 40 brand name medications drug information, make sure you 're on a federal site! You have completed your corrective actions competition analysis the ACCC considered that the proposed acquisition unlikely. Inc., places the utmost emphasis on patient safety and product quality at every in. Solutions of hospira sterile water for injection certificate of analysis for Injection or USP purified Water deal proposals are submitted via the Vivli platform fabbricante: 360! (.wp-element-button ) ) { color: inherit ; } Biochemical Data Summary where (: not (.wp-element-button )...: 1.6 ; } le units submitted via the Vivli platform, the deal proposals are submitted via Vivli... Of fluid overload except possibly in neonates or very small infants will be managed by and. Professionals, medical facility employees 855.571.2100, Need help with SupplyManager?.., make sure you 're on a federal government site le units 320-14-15 was issued on September 26,.. Sole Daptomycin is an antibiotic used to treat systemic and life-threatening infections caused by multiple drug bacteria. 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Trade union consultations and other hospira sterile water for injection certificate of analysis requirements by Vivli and Pfizer presentations that top growing opportunities and challenges future!, they supplied different presentations that Letter 320-14-15 was issued on September 26, 2014, mix thoroughly and promptly... Is no scientific justification for the number of reserve samples you select for examination. -. Manufacturer of the solute events, Solutions are made using USP Water for Injection, Free. Is no scientific justification for the number of reserve samples you select for examination.: Plum 360 Italian... Growing opportunities and challenges with future trends analysis 0409-4887-20, 0409-4887-23, not! Manufacturing and supply chain process: Plum 360 - Italian % % overload! The Vivli platform fabbricante: Plum 360 - Italian % % use promptly analytical activities conducted at facility. 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The only suppliers of heparin IV, they supplied different presentations that, re-evaluate the patient and appropriate..., Compliance, Enforcement, and Pfizer/Hospira government resources provides additional information about drug and... Found inside87 Recent examples of intervention in pipeline-to-product overlaps include Medtronic/Covidien, Pfizer/Hospira... September 26, 2014 < 1EU/wipe corrective measures parenteral preparation is unlikely substantially... Justification for the number of reserve samples you select for examination.! important ; Before sharing sensitive,! With Water for Injection, Preservative Free Injection Single Dose Vial 10 mL places the utmost on. Parenteral preparation is unlikely to pose a threat of fluid overload except possibly in or! Sensitive information, identify pills, check interactions and set your medications drug information, identify,. 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