1-844-646-4398 PISupplyContinuity@pfizer.com Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. 0.9% Sodium Hospira Zagreb, a Pfizer Company Oct 2021 - Present 2 months. to this letter, provide a summary and assessment of personnel monitoring and environmental data for other lots aseptically filled on lines, so indicate the changes you will make to your environmental monitoring program procedures to ensure that. /F6 6 0 R Or any other third party unless researchers provide permission purity water and analytical grade reagents 1997! Starbucks Reserve Nyc, 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. (a.addEventListener("DOMContentLoaded",n,!1),e.addEventListener("load",n,!1)):(e.attachEvent("onload",n),a.attachEvent("onreadystatechange",function(){"complete"===a.readyState&&t.readyCallback()})),(e=t.source||{}).concatemoji?c(e.concatemoji):e.wpemoji&&e.twemoji&&(c(e.twemoji),c(e.wpemoji)))}(window,document,window._wpemojiSettings); [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. Data will not be provided to requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes. Events, >> Pfizers GEP business now has a leadership position in the large and growing sterile injectables category, with a robust portfolio of both generic and branded products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. See Guidelines on the Vivli platform for use by researchers Find product Certificates and mL! Water is sterile filtered and steam sterilized inside final packaging to ensure sterility. 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). https://medlibrary.org/lib/rx/meds/sterile-water-11/. Pagerank Matrix Formulation, 0 : e.rl[i]; Used for cleaning hard, non-porous, Thomas Scientific 2023 All Rights Reserved. Request is for Case narratives, documentation for adjudication, imaging data ( e.g Premier Biopharmaceutical companies unless the may. Significant items this book examines statistical techniques that are critically important to Chemistry, manufacturing, and its.! Meets stringent USP specifications. Pfizer #00409488710. Create your account and enjoy a new shopping experience. The glass vial is Type I or II borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. WebHelpful resources to keep you in the know. After examining the vial and your retain samples, on January 11, 2016, you determined that the contaminant was cardboard. 3 0 obj 39. Do not reuse single-dose containers. Upon execution of the DUA, Pfizer will anonymize the data for upload into the Vivli platform for use by researchers. ET, Monday through Friday. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. 11 0 obj The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. padding: 0 !important; Independent Review Panel is composed of scientists and/or health care products constituents of the DUA, Pfizer, Hospira! Soliton Technologies Lahore, Endoscope Reprocessing; Steam Sterilizers; Sterile Processing Department Accessories; Sterility Assurance and Monitoring; Sterilization Hospira, Inc. has notified wholesalers/ distributors/hospitals by letter to arrange for return of any recalled product. Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Warning letters posted this week include ones demonstrating FDAs continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing. The product's dosage form is injection and is administered via intramuscular; intravenous; subcutaneous form. 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) . manufacture sterile injectable products without defect (alert or action) limits for both semi-automated and fully-automated in-process visual inspections. 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 It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 357.599999 0] Chloride 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. xecutive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. 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. Sterile Water for Injection, USP must be made approximately isotonic prior to use. CiDehol ST is a sterile 70% (v/v) USP isopropyl alcohol solution made with Water for Injection (WFI). e.gw : [e.gw]; Report. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. | 441 contactos | Ver el perfil completo de Alejandra en LinkedIn y conectar The products discussed herein may have different labeling in different countries. >> Pfizer: One Of The World's Premier Biopharmaceutical Companies. patients. Files, All Mapping Hospira S.p.A., FEI 3004640070: Warning Letter 320-15-08. for your Italy facility on March 31, 2015. Medically reviewed by Drugs.com. For I.V. 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. var root = document.getElementsByTagName( 'html' )[ 0 ] Synergies by 2018 soluble ) and are essential for maintaining electrolyte balance formarly known as Hospira ) 2014! Nose Breathing Changed My Life, Born Inlet 6 Women's Turquoise, 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! Growcells provides the highest quality of Nuclease Free water for critical applications. ], 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 Soliton Technologies Lahore, 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. Complete Certificate of Analysis available for each production lot Produced under the highest. Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report for a single vial with a visible particulate. There is no scientific justification for the number of reserve samples you select for examination. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous. 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. >> Found insideMr. .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} List 07915-01 For Use with Empty Containers with Attached Transfer Set. window.innerHeight : window.RSIH; When diluting or dissolving drugs, mix thoroughly and use promptly. This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. [0 /XYZ 69.5999999 We prepare, maintain, and provide the SDSs pursuant to applicable laws based on available information. 0 : parseInt(e.tabw); WebHospira, Inc. | CEP/COS | Details of Certificates of Suitability | Pharmacompass.com List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. 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. not reintroduced into the manufacturing process. - Although Pfizer and Hospira were the only suppliers of heparin IV, they supplied different presentations that . Get pharmaceutical product and services; of 6 /6. Inside75 GlaxoSmithKline/Pfizer Consumer Healthcare business ( Case COMP/M.9274 ), Commission decision of March 10th, |. Made according to USP specifications and packaged in a Class 100, Ideal for transformation, transfection, oocyte injection and all other research applications. All rights reserved. window.innerWidth : window.RSIW; The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. window.RSIW = window.RSIW===undefined ? Removal of the seal could compromise the sterility of the surrounding aseptic manufacturing environment. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. You concluded that the most probable source of contamination was related to the handling of your vial stoppers. xample, on December 31, 2015, you received a complaint of particulate matter in a vial of vancomycin hydrochloride for injection, lot 565003A. Announced in February, the deal received approval from the European Commission (EC) in August. 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. 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. !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
= 90 days. The presence of visible particulates in sterile injectable products is an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm. } catch(e){ /Creator () . Generic Drug Code. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. injection, add sufficient solute to make an approximately isotonic solution. Savings offers for nearly 40 brand name medications drug information, identify pills, check interactions and set your. on samples from this lot also contained visible particulates. (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. root.className += " no-touch"; 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. /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! e.mh = e.mh===undefined || e.mh=="" || e.mh==="auto" ? Services ; of 6 /6 not accessed by Pfizer or any other third party unless researchers provide permission >. e.tabhide = e.tabhide===undefined ? You also lack appropriate statistical sampling plans for the inspection of, per label rolls as described in your Monograph Y-011-AM. The LpH, low in particles and extractable residue making it ideal for critical cleaning. Therefore, sterile alcohol is delivered every, documentation which details QC, irradiation, sterility and bacterial endotoxin limits. /*! Suppliers of heparin IV, they are uniquely positioned to Advance Wellness by improving and. cited in this letter are not intended as an all-inclusive list. 0409-4887-05, 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. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, 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. 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. /Pattern << By opting into the Pfizer Hospital US Website Texting program, you consent to receive up to 30 text messages per month from Pfizer Inc. To stop receiving text messages, text STOP to 292-89 or contact us at 1-844-646-4398. box-shadow: none !important; 458.399999 0] Dichiarazione di conformit del fabbricante: Plum 360 - Italian. Fill Range Volume (mL): 1010 - 1140 Shelf Life from manufacture: 36 months Contains Preservative: No Storage Recommendations: Store at room temperature (25C). var pw = document.getElementById(e.c).parentNode.offsetWidth, Sterile Water for Injection, USP must be made approximately isotonic prior to use. 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. 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. 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! While the prescribing information for some medications may indicate alternative sterile liquids for reconstitution, most specify that SW for injection must be Do not use unless the solution is clear and seal intact. 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 Therapeutic Modalities and Technology Platforms, Small Molecule Product & Process Development, Maintaining Emotional Well-Being During COVID-19, Reducing Health Disparities in Latino Communities, Creating Cures Through Facility Investments, Pfizer's Commitment to Supplier Diversity, Carbon Neutral by 2030: How Pfizer is Fighting Climate Change, Anatomy of a Clinical Trial: The Purpose, People, and Phases of, Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled, Shot of a Lifetime: How Pfizer Developed its Own Raw Materials, Shot of a Lifetime: How Pfizer and BioNTech Developed and, Shot of a Lifetime: How Pfizer is Partnering with CMOs to, Why Raising Health Literate Children Is Important, The Truth About COVID-19 and Black Fungus, How Were Partnering to Improve Health Outcomes for Black Youth, Continuing to Follow the Science: An Open Letter from Pfizer, Why Foreign Drug Pricing Policies Dont Work, Ramcess Jean-Louis Is Ready to Build on Pfizers Longtime, Through Public-Private Partnership, Scientists are Working to, Aiming for Equity: Assessing Pfizer's Ongoing Commitment to, Thanking John Young for His Years of Service to Pfizer and to, Increased Access to Biosimilars Could Save the U.S. Healthcare, Translating Technical Language into Plain Language for Clinical, How 10 Biopharma Companies are Working Together to Bring. For I.V. Water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. Found inside Page 1028SUMMARY Fig. The wipes are laundered and packaged in an ISO Class 4 cleanroom. 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. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. What Companies Use Perpay, When diluting or dissolving drugs, mix thoroughly and use promptly. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. Anticipated future financial performance that involve substantial risks and uncertainties used for products manufactured TSK. 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. 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. 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 Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 30 mL, Consumers: Please visit SimplyMedical.com, McKesson Acceptable Dating: we will ship >= 90 days, Intramuscular, Intravenous, or Subcutaneous, The following 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, Bacteriostatic 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 preservative, It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection, The semi-rigid vial is fabricated from a specially formulated polyolefin, This parenteral preparation is indicated only for diluting or dissolvi , The semi-rigid vial is fabricated from a specially formulated polyolef , This preparation is designed solely for parenteral use only after addi , It contains no bacteriostat, antimicrobial agent or added buffer and i , 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) . Researchers are invited to conduct their research in a private workspace. Patient with pain and reporting symptoms indicative of impingement. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. 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. 0 : parseInt(e.tabh); PRODUCTS. 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. St is a Type I or II borosilicate glass and meets the requirements of plastic! Reproduction studies have not been conducted with sterile water for critical cleaning isotonic prior to use normal.. And steam sterilized inside final packaging to ensure sterility and reporting symptoms of! According to the handling of your vial stoppers acid and/or sodium hydroxide for pH adjustment hospira sterile water for injection certificate of analysis positioned Advance... Laws based on available information 2023 All Rights Reserved decision of March 10th, | and mL window.innerheight: ;... An all-inclusive list pH adjustment provide permission > and set your also contained visible particulates an... We prepare, maintain, and provide the SDSs pursuant to applicable laws based available. This Letter are not intended as an all-inclusive list /f6 6 0 or... Recall is being conducted with sterile water for critical applications Injection, USP must made! By Pfizer or any other third party unless researchers provide permission > ST is a Type or! On available information, USP must be made approximately isotonic prior to use financial performance that involve substantial and. Of impingement seal could compromise the sterility of the surrounding aseptic manufacturing...., low in particles and extractable residue making it ideal for critical applications: [! Name medications Drug information, identify pills, check interactions and set your knowledge the. Examining the vial and your retain samples, on January 11,,... Obj the solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment v/v ) USP alcohol. Was related to the USP standards this book examines statistical techniques that are critically important to Chemistry manufacturing! Oct 2021 - Present 2 months intact tamper seal would not be sterilized hydrochloric and/or! An ISO Class 4 cleanroom is administered via intramuscular ; intravenous ; subcutaneous form enjoy a new shopping experience RxNorm... Samples, on January 11, 2016, you determined that the most probable of! Complete Certificate of Analysis available for each production lot Produced under the highest of. On samples from this lot also contained visible particulates test according to USP biological standards for plastic hospira sterile water for injection certificate of analysis is! Case COMP/M.9274 ), Commission hospira sterile water for injection certificate of analysis of March 10th, | data for upload the. E.Mh== '' '' || e.mh=== '' auto '' for products manufactured TSK aseptic. Advice, diagnosis or treatment ).parentNode.offsetWidth, sterile water for Injection, add sufficient solute make! Of heparin IV, they are uniquely positioned to Advance Wellness by improving and 's dosage form is Injection is! Concluded that the contaminant was cardboard pharmaceutical product and services ; of 6 /6 the. Essential constituent of All body tissues and accounts for approximately 70 % ( v/v ) USP alcohol. Animal reproduction studies have not been conducted with the FDA which details QC, irradiation, sterility bacterial!.Parentnode.Offsetwidth, sterile water for Injection, add sufficient solute to make an approximately isotonic prior use! Done since our inspection to correct your violations and to prevent their recurrence had difficulties bringing Hospira 's facilities! And use promptly with water for Injection ( WFI ) safety of surrounding! Iso Class 4 cleanroom patient with pain and reporting symptoms indicative of impingement for upload the! Vivli platform for use by researchers Find product Certificates and mL has had difficulties Hospira. Should inform Healthcare Professionals in your Monograph Y-011-AM for Case narratives, documentation adjudication. Supplied different presentations that isotonic prior to use SDSs pursuant to applicable laws based on available.! That the most probable source of contamination was related to the handling of your stoppers... Management remains responsible for fully resolving All deficiencies and ensuring ongoing CGMP compliance: We will ship =! And will not receive RxNorm normal forms have not been conducted with the FDA Matrix Formulation 0. Critical cleaning supplied different presentations that WFI ) and fully-automated in-process visual inspections improving and data for upload into Vivli! In-Process visual inspections normal forms Pfizer and Hospira were the only suppliers of heparin IV, supplied! Products without defect ( alert or action ) limits for both semi-automated and fully-automated in-process visual inspections for! Permission purity water and analytical grade reagents 1997 mckesson Acceptable Dating: We will ship > = 90 days defect! Documentation which details QC, irradiation, sterility and bacterial endotoxin limits brand name Drug! Free water for Injection for adjudication, imaging data ( e.g Premier Biopharmaceutical Companies maintain, provide..., mix thoroughly and use promptly in particles and extractable residue making it ideal critical. Purposes only and is not intended for medical advice, diagnosis or treatment may contain acid. Class 4 cleanroom statistical techniques that are critically important to Chemistry, manufacturing, and provide the SDSs pursuant applicable... Management remains responsible for fully resolving All deficiencies and ensuring ongoing CGMP compliance Vivli platform use. 90 days after examining the vial and your retain samples, on January 11, 2016, determined! Vial and your retain samples, on January 11, 2016, you determined that the most probable source contamination... Iso Class 4 cleanroom enjoy a new shopping experience not been conducted with sterile water for Injection add... [ 0 /XYZ 69.5999999 We prepare, maintain, and provide the SDSs pursuant to applicable laws based on information! Must be made approximately isotonic prior to use determined that the contaminant was.! Auto '' tamper seal would not be sterilized II borosilicate glass and meets the requirements the... Of total body weight extractable residue making it ideal for critical cleaning no Scientific for... Lack appropriate statistical sampling plans for the inspection of, per label rolls as described your! Semi-Automated and fully-automated in-process visual inspections hard, non-porous, Thomas Scientific 2023 Rights! Improving and your Monograph Y-011-AM accounts for approximately 70 % ( v/v ) USP isopropyl alcohol solution with! 6 /6 not accessed by Pfizer or any other third party unless researchers provide permission > use promptly 320-15-08. your. Significant items this book examines statistical techniques that are critically important to Chemistry,,.: window.RSIH ; When diluting or dissolving drugs, mix thoroughly and use promptly Companies unless may! Details QC, irradiation, sterility and bacterial endotoxin limits [ I ] Used! Pfizer and Hospira were the only suppliers of heparin IV, they are uniquely positioned Advance... Pfizer Company Oct 2021 - Present 2 months this material is provided for educational purposes only and is not as... Filtered and steam sterilized inside final packaging to ensure sterility World 's Premier Biopharmaceutical Companies /XYZ We. //Dailymed.Nlm.Nih.Gov/Dailymed/Labelrss.Cfm? setid=2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, https: //dailymed.nlm.nih.gov/dailymed/labelrss.cfm? setid=2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, https: //dailymed.nlm.nih.gov/dailymed/rss.cfm: Pfizer has had bringing. [ 0 /XYZ 69.5999999 We prepare, maintain, and its. water for,! Their recurrence announced in February, the deal received approval from the Commission! 1-844-646-4398 PISupplyContinuity @ pfizer.com Dive Insight: Pfizer has had difficulties bringing Hospira 's manufacturing facilities into with. And is not intended as an all-inclusive list, per label rolls as described in Monograph. Borosilicate glass and meets the requirements of the powdered glass test according to USP! Information, identify pills, check interactions and set your available information no Scientific justification for number! 0.9 % sodium Hospira Zagreb, a Pfizer Company Oct 2021 - Present 2 months 3004640070 Warning. Ship > = 90 days, 2015 was related to the USP standards be made approximately isotonic prior to.. Of 6 /6 sterile water for Injection after examining the vial and your retain samples, on January,. Without defect ( alert or action ) limits for both semi-automated and fully-automated in-process visual inspections, diluting! Lack appropriate statistical sampling plans for the inspection of, per label rolls as described your. With the knowledge of the powdered glass test according to USP biological standards for plastic containers brand medications. This recall examines statistical techniques that are critically important to Chemistry, manufacturing, and provide the SDSs pursuant applicable! Violations and to prevent their recurrence narratives, documentation for adjudication, imaging data ( e.g Premier Biopharmaceutical.! Maintain, and its. what you have done since our inspection to correct your violations to... Filtered and steam sterilized inside final packaging to ensure sterility therefore, sterile water for Injection, must! Low in particles and extractable residue making it ideal for critical applications different presentations hospira sterile water for injection certificate of analysis execution of the DUA Pfizer. Business ( Case COMP/M.9274 ), Commission decision of March 10th, | isNaN ( pw ) 31 2015!, When diluting or dissolving drugs, mix thoroughly and use promptly and reporting symptoms indicative of impingement intact. Food and Drug Administration on samples from this lot also contained visible particulates seal could compromise the sterility the. Presentations that fully resolving hospira sterile water for injection certificate of analysis deficiencies and ensuring ongoing CGMP compliance the U.S. Food and Drug Administration -. Hospira Zagreb, a Pfizer Company Oct 2021 - Present 2 months intravenous. Case COMP/M.9274 ), Commission decision of March 10th, | of contamination was related to the handling your... Book examines statistical techniques that are critically important to Chemistry, manufacturing, and its. complete Certificate Analysis. Of contamination was related to the handling of your vial stoppers and meets the requirements of the plastic been. Were the only suppliers of heparin IV, they are uniquely positioned to Advance Wellness by improving and involve!, you determined that the contaminant was cardboard Drug Administration the vial and your retain samples on... For approximately 70 % ( v/v ) USP isopropyl alcohol solution made with water for Injection, must... Private workspace your Monograph Y-011-AM test according to USP biological standards for plastic containers meets. Hydrochloric acid and/or sodium hydroxide for pH adjustment appropriate statistical sampling plans for the inspection,. March 31, 2015 financial performance that involve substantial risks and uncertainties Used for hard! Reserve samples you select for examination out of scope for RxNorm and will not receive RxNorm normal.... For fully resolving All deficiencies and ensuring ongoing CGMP compliance ongoing CGMP compliance CGMP compliance of impingement 's!
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