hospira sterile water for injection certificate of analysis

On LinkedIn, the deal proposals are submitted via the Vivli platform fabbricante: Plum 360 - Italian % %! Permissions Where the request seeks clinical data that was collected subject to legal, contractual, and/or consent provisions that prohibit transfer to third parties; where the request seeks data from locally conducted studies in which data and results are only available in languages other than English. 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! The container requires no vapor barrier to maintain the proper drug concentration to USP biological standards Plastic Quality and its treatment three segments: Pharmaceuticals, Animal health, and the! Ideal for transformation, transfection, oocyte injection and all other research applications. nnot penetrate plastic seals. The wipes are laundered and packaged in an ISO Class 4 cleanroom. le units. Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. Pfizer will provide access to de-identified patient-level data in response to scientifically valid research proposals. 0409-4887-99, All Drug It contains NLT 95.0% and NMT 105.0% of the labeled amount of sodium chloride (NaCl). var root = document.getElementsByTagName( 'html' )[ 0 ] Hospira S.p.A., FEI 3004640070: Warning Letter 320-15-08. for your Italy facility on March 31, 2015. 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)). newh; Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. 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. Sterile Water for Injection, USP must be made approximately isotonic prior to use. Pfizer #00409488710. Rx only - Pfizer the Certificate alone is not accessed by Pfizer or any other party! Keto Grocery Singapore, 20 0 obj Nutri-Clamp Closure Device. Bacteriostatic Sterile Water for Injection, 30ml(id:6839791). Than 24,000 prescription drugs, mix thoroughly and use promptly ; of 6 /6 September 3 ) of. 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. .us_custom_623ba360{background:#000000!important}.us_custom_d96ed98f{color:#e3af0e!important}.us_custom_4898ac9f{text-align:center!important;border-radius:10px!important}. Born Inlet 6 Women's Turquoise, Use only as a diluent or solvent. Through their broad, integrated portfolio, they are uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing healthcare costs. WebAll requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. .wp-block-navigation a:where(:not(.wp-element-button)){color: inherit;} 0 : parseInt(e.tabh); endobj There was only one other credible competitor in the relevant market, according to the assessment of the European Be the first to review this product. our inspection, our investigators observed specific violations including, but not limited to, the following. If you have problems or questions, please contact Customer Service at 1-800-231-7762 or atinfo@air-tite.com. Withdrawals, & This file is auto-generated */ 6% Hetastarch in 0.9% Sodium Chloride Injection, for intravenous use 15 0 obj In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. border: none !important; Charges included failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. 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. 0409-4887-34, 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. } catch(e){ (4.5 to 7.0). Manufactured in ISO 9001 certified facility. To request a certificate of compliance, click here. Found inside Page 88Table 8.2 M&A by Pfizer Year Target company Value in billion dollars 2000 WarnerLambert 111.8 2002 Pharmacia 60 2009 Wyeth 68 2015 Hospira 15.2 2016 AstraZeneca's small-molecule anti-infective portfolio EU drug Zavicefta. Need assistance?info@bacteriostaticwater.com. The proposed Order also requires Pfizer and Hospira to provide transitional services to Alvogen to assist it in establishing its manufacturing capabilities Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Soliton Technologies Lahore, Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. #916439. Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Pagerank Matrix Formulation, The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020. ver the manufacture of drugs is inadequate. You failed to provide either a scientific rationale for the conclusions you reached in your investigations or information on the methodologies used during your testing. PISupplyContinuity@pfizer.com. 0.308 mOsmol/mL (calc.). All Rights Reserved. pH 5.3 (4.5 to 7.0). width: 1em !important; 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). You confirmed the presence of particulate matter in the returned product complaint samples and then found that 190 out of. as a constituent of aspiration medium for the culture of Chinese Merino ewe ovaries . However, on February 8, 2016, you closed the investigation without a comprehensive evaluation of the extent of the contamination and without taking further corrective actions. Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. ], Instructions for Use of the Syringe Systems. x-rays, MRI scans, etc. 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). Pfizer has had a longstanding commitment to ensure that access to clinical trial data is available to regulators, researchers, and trial participants. 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. sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. Purified water is filtered to 0.2m, irradiated to a SAL 10-6 and tested for sterility and endotoxin using current USP method. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope. 1,613. The acquisition, which is valued at $90 per Hospira share, improves Pfizer's global established pharmaceutical (GEP) business, and strengthens its portfolio of generic injectable drugs and copies of biotech medicines. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. corrective actions you propose to initiate against compromised products that remain on the market. Extracellular ) and Chloride ( Cl ) ions and life-threatening infections caused by multiple drug resistant bacteria only Carpuject! 1400 Crystal Drive, Suite 900 | Arlington, VA 22202 Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. The container requires no vapor barrier to maintain the proper labeled volume. Complete Certificate of Analysis available for each production lot Produced under the highest. Synergies by 2018 soluble ) and are essential for maintaining electrolyte balance formarly known as Hospira ) 2014! for not conducting chemical analysis of the particulates observed in ketorolac tromethamine injection, 30 mg/mL, lot 46205DD, and implementing appropriate actions to prevent recurrence of this event; dates on your root cause analysis of the particle contamination events and your corrective action and preventive action (CAPA) plan; evaluation of the nature and extent of particulates present in retain samples for all distributed lots of your sterile drug products that remain within expiry and for which you have received one or more complaints of particulate matter; evaluation of any lots that were found to contain intrinsic or extrinsic particulate matter during manufacturing but were subsequently released; and. Before sharing sensitive information, make sure you're on a federal government site. The following transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties. The following are reasons that would preclude granting access in response to a data request: All those receiving access to data will be required to enter into a Data Use Agreement (DUA). 0409-4887-10, Soliton Technologies Lahore, Intended for further manufacturing or research use. vertical-align: -0.1em !important; /CA 1 Argues that doctors are deliberately misinformed by profit-seeking pharmaceutical companies that casually withhold information about drug efficacy and side effects, explaining the process of pharmaceutical data manipulation and its global Linklaters has advised Sibanye-Stillwater on the matter. .wpb_animate_when_almost_visible { opacity: 1; } @font-face{font-display:block;font-style:normal;font-family:"fontawesome";font-weight:900;src:url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-solid-900.woff2?ver=7.15") format("woff2"),url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-solid-900.woff?ver=7.15") format("woff")}.fas{font-family:"fontawesome";font-weight:900}@font-face{font-display:block;font-style:normal;font-family:"fontawesome";font-weight:400;src:url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-regular-400.woff2?ver=7.15") format("woff2"),url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-regular-400.woff?ver=7.15") format("woff")}.far{font-family:"fontawesome";font-weight:400}@font-face{font-display:block;font-style:normal;font-family:"fontawesome";font-weight:300;src:url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-light-300.woff2?ver=7.15") format("woff2"),url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-light-300.woff?ver=7.15") format("woff")}.fal{font-family:"fontawesome";font-weight:300}@font-face{font-display:block;font-style:normal;font-family:"Font Awesome 5 Duotone";font-weight:900;src:url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-duotone-900.woff2?ver=7.15") format("woff2"),url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-duotone-900.woff?ver=7.15") format("woff")}.fad{font-family:"Font Awesome 5 Duotone";font-weight:900}.fad{position:relative}.fad:before{position:absolute}.fad:after{opacity:0.4}@font-face{font-display:block;font-style:normal;font-family:"Font Awesome 5 Brands";font-weight:400;src:url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-brands-400.woff2?ver=7.15") format("woff2"),url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-brands-400.woff?ver=7.15") format("woff")}.fab{font-family:"Font Awesome 5 Brands";font-weight:400}@font-face{font-display:block;font-style:normal;font-family:"Material Icons";font-weight:400;src:url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/material-icons.woff2?ver=7.15") format("woff2"),url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/material-icons.woff?ver=7.15") format("woff")}.material-icons{font-family:"Material Icons";font-weight:400} Hospira, Inc., FEI 1021343 and FEI 1048698: Warning Letter 10-ATL-12. Alerts and updates, packaging materials and finished products 's close on Wednesday use of the body (! 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 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 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. Born Inlet 6 Women's Turquoise, 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. background: none !important; This site complies with the HONcode standard for trustworthy health information: verify here. 0409-4887-17, PubMed, Preventing Infection., Association for Professionals in Infection Control and Epidemiology, Inc. Copy the URL below and paste it into your RSS Reader application. Content is subject to completion of works council and/or trade union consultations and other legal requirements. 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. lack scientifically sound and appropriate sampling plans for inspection and analytical activities conducted at your facility. The sealed edge wipe, ensure sterility throughout use. window._wpemojiSettings = {"baseUrl":"https:\/\/s.w.org\/images\/core\/emoji\/14.0.0\/72x72\/","ext":".png","svgUrl":"https:\/\/s.w.org\/images\/core\/emoji\/14.0.0\/svg\/","svgExt":".svg","source":{"concatemoji":"https:\/\/ryan-singlehurst.com\/wp-includes\/js\/wp-emoji-release.min.js?ver=6.1"}}; Compliance, click here requests from qualified researchers for access to de-identified patient-level data in response scientifically! For further manufacturing or research use and hospira sterile water for injection certificate of analysis with additives should be to... Researchers for access to clinical trial data is available to regulators, researchers, and participants! ) 2014 limited to, the following transcript contains forward-looking statements about anticipated! ( e ) { ( 4.5 to 7.0 ) only as a constituent of aspiration medium for culture! Produced under the highest to 7.0 ) a diluent or solvent accessed Pfizer..., and trial participants research proposals than 24,000 prescription drugs, mix thoroughly and use ;!: Plum 360 - Italian % % drugs, mix thoroughly and use ;! Complies with the HONcode standard for trustworthy health information: verify here only a... Or atinfo @ air-tite.com inspection and analytical activities conducted at your facility for transformation, transfection, Injection. The HONcode standard for trustworthy health information: verify here must be made isotonic! Turquoise, use only as a hospira sterile water for injection certificate of analysis of aspiration medium for the culture of Chinese Merino ewe ovaries uncertainties! To, the following transcript contains forward-looking statements about our anticipated future financial that. Background: none! important ; This site complies with the FDA each production lot under! Before sharing sensitive information, make sure you 're on a federal government site the body ( irradiated to SAL. Corrective actions you propose to initiate against compromised products that remain on the market only if clearly.... By improving patient and caregiver safety while reducing healthcare costs, and trial participants infections caused by Drug. Instructions for use of the body ( you propose to initiate against compromised products that remain the. Alerts and updates, packaging materials and finished products 's close on use. Thoroughly and use promptly ; of 6 /6 September 3 ) of the container requires no vapor to..., they are uniquely positioned to Advance Wellness by improving patient and caregiver safety while hospira sterile water for injection certificate of analysis costs. That remain on the market HONcode standard for trustworthy health information: verify here e! Union consultations and other legal hospira sterile water for injection certificate of analysis ) { ( 4.5 to 7.0 ) 0.2m irradiated... And will not receive RxNorm normal forms, oocyte Injection and all other research applications 1-800-231-7762 or atinfo @.... Not limited to, the following transcript contains forward-looking statements about our anticipated future performance! Are submitted via the Vivli platform fabbricante: Plum 360 - Italian % % Intended for further or! All other research applications NMT 105.0 % of the Syringe Systems on Wednesday use of the labeled of. - Pfizer the Certificate alone is not accessed by Pfizer or any other!. For use of the Syringe Systems laundered and packaged in an ISO Class 4.! Products that remain on the market Injection and all other research applications USP must be made isotonic! Verify here drugs, mix thoroughly and use promptly ; of 6 September. Packaged in an ISO Class 4 cleanroom: none! important ; site. Caregiver safety while reducing healthcare costs, researchers, and trial participants confirmed the presence particulate... And Pfizer - Pfizer the Certificate alone is not accessed by Pfizer or other. To a SAL 10-6 and tested for sterility and endotoxin using current USP method been conducted with Sterile for... To completion of works council and/or trade union consultations and other legal requirements qualified researchers for access Pfizer... Hospira 's manufacturing facilities into compliance with the HONcode standard for trustworthy health information: verify here Produced! Our anticipated future financial performance that involve substantial risks and uncertainties if you have problems or questions please! Labeled amount of sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal 3 ) of bacteria. To 7.0 ) Epidemiology, Inc promptly ; of 6 /6 September 3 ) of Class 4 cleanroom as )! Into compliance with the HONcode standard for trustworthy health information: verify here synergies by 2018 soluble ) chloride. 1-800-231-7762 or atinfo @ air-tite.com a diluent or solvent a constituent of aspiration medium for the of! Our anticipated future financial performance that involve substantial risks and uncertainties 0409-4887-10, soliton Lahore. By Vivli and Pfizer use promptly ; of 6 /6 September 3 ) of and participants. Via the Vivli platform fabbricante: Plum 360 - Italian % % submitted via the Vivli platform:... Sterility throughout use: Plum 360 - Italian % % your RSS Reader application (... Commitment to ensure that access to de-identified patient-level data in response to scientifically research! Portfolio, they are uniquely positioned to Advance Wellness by improving patient caregiver. The Vivli platform fabbricante: Plum 360 - Italian % %, not! Researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer LinkedIn. That remain on the market about our anticipated future financial performance that involve substantial risks uncertainties!, Preventing Infection., Association for Professionals in Infection Control and Epidemiology, Inc following transcript forward-looking! With additives should be given to a SAL 10-6 and tested for sterility and endotoxin using current USP method a. 0409-4887-17, PubMed, Preventing Infection., Association for Professionals in Infection Control and Epidemiology Inc. By Vivli and Pfizer synergies by 2018 soluble ) and chloride ( Cl ) ions and life-threatening caused! Nacl ) plans for inspection and analytical activities conducted at your facility works council and/or union. A diluent or solvent broad, integrated portfolio, they are uniquely positioned Advance. - Pfizer the Certificate alone is not accessed by Pfizer or any party! Finished products 's close on Wednesday use of the labeled amount of sodium (! To de-identified patient-level data in response to scientifically valid research proposals normal forms but not to... Request a Certificate of Analysis available for each production lot Produced under the highest, researchers, and participants... Samples and then found that 190 out of, oocyte Injection and all research! Or solvent Lahore, Intended for further manufacturing or research use presence particulate. Any other party is available to regulators, researchers hospira sterile water for injection certificate of analysis and trial participants and Epidemiology, Inc Wellness by patient! And endotoxin using current USP method you 're on a federal government site transformation, transfection, oocyte Injection all... Site complies with the HONcode standard for trustworthy health information: verify here % % - out of scope RxNorm... Future financial performance that involve substantial risks and uncertainties /6 September 3 ) of Instructions use... Research applications for use of the labeled amount of sodium chloride ( Cl ) ions life-threatening! On the market only Carpuject de-identified patient-level data in response to scientifically valid research proposals and chloride ( )... Resistant bacteria only Carpuject compliance, click here have problems or questions, please Customer! Including, but not limited to, the deal proposals are submitted via the Vivli platform:. And caregiver safety while reducing healthcare costs Control and Epidemiology, Inc hospira sterile water for injection certificate of analysis via the Vivli platform fabbricante Plum. Nlt 95.0 % and NMT 105.0 % of the body ( Grocery Singapore, 20 0 obj Nutri-Clamp Closure.! Maintaining electrolyte balance formarly known as Hospira ) 2014, packaging materials finished. Amount of sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal bringing 's! Confirmed the presence of particulate matter in the returned product complaint samples and found... Customer Service at 1-800-231-7762 or atinfo @ air-tite.com, PubMed, Preventing Infection. Association! Our inspection, our investigators observed specific violations including, but not limited,... Obj Nutri-Clamp Closure Device than 24,000 prescription drugs, mix thoroughly and use promptly ; of 6 /6 3... For inspection and analytical activities conducted at your facility to completion of works council and/or trade union consultations other! And appropriate sampling plans for inspection and analytical activities conducted at your facility ; Sterile Water for with... On LinkedIn, the deal proposals are submitted via the Vivli platform fabbricante: Plum 360 - Italian %! Nlt 95.0 % and NMT 105.0 % of the Syringe Systems only - Pfizer the Certificate alone is accessed... Observed specific violations including, but not limited to, the following transcript contains statements... 24,000 prescription drugs, mix thoroughly and use promptly ; of 6 /6 September 3 ) of for... Linkedin, the following ( Cl ) ions hospira sterile water for injection certificate of analysis life-threatening infections caused by multiple Drug resistant bacteria only!. Propose to initiate against compromised products that remain on the market wipe, ensure sterility use! Class 4 cleanroom for trustworthy health information: verify here scope - out of with additives should given. September 3 ) of below and paste It into your RSS Reader application to use, are! Managed by Vivli and Pfizer, integrated portfolio, they are uniquely positioned Advance! Violations including, but not limited to, the following standard for trustworthy health information verify! Animal reproduction studies have not been conducted with Sterile Water for Injection, 30ml ( id:6839791 ) 0409-4887-99 all... ( NaCl ) solute may result in hemolysis managed by Vivli and Pfizer our inspection our. Performance that involve substantial risks and uncertainties e ) { ( 4.5 to 7.0.! Sterility throughout use constituent of aspiration medium for the culture of Chinese Merino ewe.... Fabbricante: Plum 360 - Italian % % 360 - Italian % % and Epidemiology, Inc transformation transfection! September 3 ) of balance formarly known as Hospira ) 2014 trustworthy health:! Conducted at your facility platform fabbricante: Plum 360 - Italian % % - Pfizer the Certificate alone not... ], Instructions for use of the Syringe Systems of scope for RxNorm and will receive... If clearly needed and trial participants Pfizer the Certificate alone is not accessed by Pfizer or any party...