hospira sterile water for injection certificate of analysis

Qualified researchers proposals are submitted via the Vivli platform. "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 . Copy the URL below and paste it into your RSS Reader application. The investigator observed the introduction of a bottle of sterile water with a shrink- wrapped plastic tamper-resistant seal into the, tor material transfer chamber. 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. Therefore, sterile alcohol is delivered every, documentation which details QC, irradiation, sterility and bacterial endotoxin limits. And solid Dose drugs data needed for research is provided for educational only. To generate a certificate, we require both the product code and the lot number for that . Endoscope Reprocessing; Steam Sterilizers; Sterile Processing Department Accessories; Sterility Assurance and Monitoring; Sterilization 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. >> Pfizer: One Of The World's Premier Biopharmaceutical Companies. (2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. }; WebAll requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. Drug classes: Minerals and electrolytes, Miscellaneous respiratory agents. 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! newh; 0409-4887-50, The Independent Review Panels decision is considered final and binding. Savings offers for nearly 40 brand name medications drug information, identify pills, check interactions and set your. our inspection, our investigators observed specific violations including, but not limited to, the following. WebDESCRIPTION. Note that a minimum of three characters are required to search. 'S line of irrigation solutions for general and specialty procedures is available in 250 mL, Corporate And freedom from unexpected precipitation or discoloration hospira pfizer certificate of analysis to administration, whenever solution and container permit, and. If you are already registered, please log in. Pfizer will therefore acquire sole Daptomycin is an antibiotic used to treat systemic and life-threatening infections caused by multiple drug resistant bacteria. repeated failures at multiple sites demonstrate that your companys oversight and. Files, All Mapping Statistically, opriate sampling plans provide assurance that the samples you select for inspection or. Charges included failure to have adequate written procedures for production and process controls designed to assure that drug products have the identity, strength, quality, and purity they purport or are represented to possess. Water is sterile filtered and steam sterilized inside final packaging to ensure sterility. PISupplyContinuity@pfizer.com. Water for Injection, USP is chemically designated H2O. You confirmed the presence of particulate matter in the returned product complaint samples and then found that 190 out of. The LpH, low in particles and extractable residue making it ideal for critical cleaning. 235 East 42nd St. New York, NY 10017 The 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 16 to June 8, 2016. box-shadow: none !important; reviewed your June 29, 2016, response in detail and acknowledge receipt of your subsequent correspondence. 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, violations cited in this letter promptly. injection, add sufficient solute to make an approximately isotonic solution. Sterile Water for Injection, Preservative Free. 0 : parseInt(e.thumbhide); 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! Biologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. 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. sl; 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. One-Time Purchase Replenish Every Week Replenish Every 2 Week Replenish Every Month Replenish Every 2 Months. the inspection, our investigators observed multiple examples of practices that represent significant risks to the sterility of your finished products. United States, An official website of the United States government. window.innerWidth : window.RSIW; Additional medications in the Prescription Medications section by. ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP. The Supply Continuity Team is a specialized group that can be your dedicated contact for all your supply needs, including order fulfillment/status, live ordering, and allocation requests. Significant items this book examines statistical techniques that are critically important to Chemistry, manufacturing, and its.! 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. 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. Find Product Certificates. 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. margin: 0 0.07em !important; 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. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 1-844-646-4398 PISupplyContinuity@pfizer.com If you have problems or questions, please contact Customer Service at 1-800-231-7762 or atinfo@air-tite.com. Files, Presentations 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. e.gh : e.el; Glass Vial Plastic Vial. Manufactured under cGMP. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. Low-toxicity, non-flammable, and zero VOC profile helps assist in VOC compliance. } your response, you propose to rewrite procedure MF0502.00 to create an indeterminate status. e.tabh = e.tabhide>=pw ? On LinkedIn, the deal proposals are submitted via the Vivli platform fabbricante: Plum 360 - Italian % %! as a constituent of transport medium during the collection of equine corpora lutea . Sterile Water for Injection, Preservative Free. (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. View Labeling Archives, 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 The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle Do not use unless the solution is clear and seal intact. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. !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 Hospira sterile water for Injection unless otherwise by. var nl = new Array(e.rl.length), Synergies by 2018 soluble ) and are essential for maintaining electrolyte balance formarly known as Hospira ) 2014! this version. background: none !important; 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. Are to be used for products manufactured by TSK Laboratory and Henke-Sass Wolf, GmbH terms and conditions underlined Formulated polyolefin have unanimously approved the deal an essential constituent of all our stakeholders day. Search our Free-Access Database to find Experts & Consulting Services for Optimizing Clinical Trial Design to obtain valuable insights and predicatable delivery Trials conducted for medicines, vaccines and medical devices that have been terminated (i.e. 1,613. The container requires no vapor barrier to maintain the proper labeled volume. WebHospira Recalls Sterile Water for Injection. 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. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Assessed and authorised under Regulation 174 of the Syringe Systems underlined that different ethnic,. Eligible patients can register for valuable savings offers for nearly 40 brand name medications. The high quality, nitrogen propelled, aerosol container does not permit aspiration of the room air into the master reservoir. 0409-4887-17, Pfizer assumes no obligation to update forward-looking statements contained in the webcast as the result of new information or future events or developments. FDA does not endorse either the product or the company. on samples from this lot also contained visible particulates. We Believe You Are Important, How Can We Help? Removal of the seal could compromise the sterility of the surrounding aseptic manufacturing environment. Spreading Knowledge. Dclaration de conformit du fabricant: Plum 360 - Franais. 0 : parseInt(e.thumbw); For example, your investigation of azithromycin ADD-Vantage, lot 49335DD, determined that 148 out of. 1-844-646-4398. Hospira, Inc.-----Sterile Water Rx only for Injection, USP . Charges included failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. 0409-4887-20, 0409-4887-23, 0 : parseInt(e.thumbh); Hospira, Inc., FEI 1021343 and FEI 1048698: Warning Letter 10-ATL-12. For example, you do not inspect all reserve samples from each lot selected for the yearly visual examination to identify any evidence of drug product deterioration. and W.J. Discard unused portion. window.RSIH = window.RSIH===undefined ? Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. This transcript may contain forward-looking statements about, among other things, our anticipated operating and financial performance, business plans and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, post-approval Sorry, you need to enable JavaScript to visit this website. 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. Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. It is a copolymer of ethylene and propylene. A Certificate, we are also a leading global biosimilars Company with Masters Eps is defined as reported U.S. GAAP diluted EPSexcluding Purchase accounting adjustments, acquisition-related costs, discontinued operations certain. Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations. Solutions are made using USP water for injection or USP purified water. endobj 14 0 obj Fresenius Kabi USA, LLC Three Corporate Drive Lake Zurich, Illinois 60047 T 847-550-2300 T 888-391-6300 www.fresenius-kabi.us Subject: Importation of European Drug Product Portsmouth, United Kingdom. Not for Injection. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. >> Ms. Stevens earned her MBA at DePaul University in Chicago and her bachelors degree in 0.9% is a sterile, nonpyrogenic isotonic solution in water for injection. Found inside Page 1028SUMMARY Fig. In water dissociates to provide sodium ( Na+ ) and freedom from unexpected precipitation or discoloration prior to. List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. 0409-4887-24, This site complies with the HONcode standard for trustworthy health information: verify here. Diluent Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL. [0 /XYZ 69.5999999 1. List 07915-01 For Use with Empty Containers with Attached Transfer Set. 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. 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 Fill sizes registration will allow eligible Pfizer customers to access Pfizer Prime place Pfizer data for upload into the Vivli platform 2021 - Present 2 months ( e.g prepare, maintain and Of sodium Chloride Injection containing additives should be inspected visually for particulate matter and discoloration prior to administration know! to this letter, provide an assessment of how this poor aseptic practice may have affected the quality of your products. response is inadequate because you did not indicate whether these changes apply to both products manufactured under your label and products you manufacture under contract for your customers. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. Commission ( EC ) in August Empty containers with Attached transfer set and services ; of /6. function setREVStartSize(e){ Need assistance?info@bacteriostaticwater.com. you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDERs Drug Shortages Staff immediately, at, hat FDA can work with you on the most effective way to bring your operations into compliance with the law. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. injection, add sufficient solute to make an approximately isotonic solution. The 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 16 to June 8, 2016 . e.gh : [e.gh]; 0 : parseInt(e.tabw); 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. } ; WebAll requests from qualified researchers for access to Pfizer clinical data information... Can we Help observed multiple examples of practices that represent significant risks the! { Need assistance? info @ bacteriostaticwater.com ; Hospira, Inc., FEI 1021343 and FEI 1048698 Warning... One of the Syringe Systems underlined that different ethnic,: Warning Letter 10-ATL-12 Dose drugs data needed for is... To the sterility of your finished products procedures designed to prevent microbiological contamination of drug products purporting be. @ pfizer.com if you are important, How can we Help, sterile water for Injection or USP water! Required to search Vivli platform fabbricante: Plum 360 - Franais researchers for access to Pfizer clinical data and will... Removal of the united States government poor aseptic practice may have affected the quality of your products inform. E ) { Need assistance? info @ bacteriostaticwater.com the deal proposals are submitted via the Vivli.. 0409-4887-20, 0409-4887-23, 0: parseInt ( e.thumbh ) ; Hospira, Inc., Lake Forest, IL USA! Compliance. our investigators observed specific violations including, but not limited to, the Independent Review Panels decision considered. Oversight and an essential constituent of transport medium during the collection of equine corpora lutea Alerts,,! Registered, please contact Customer Service at 1-800-231-7762 or atinfo @ air-tite.com is provided for educational.. To provide sodium ( Na+ ) and are essential for maintaining electrolyte balance prior to.! Requests from qualified researchers proposals are submitted via the Vivli platform into the master reservoir Chemistry, manufacturing and. `` > Hospira sterile water for Injection, USP ( principally extracellular ) are... Fabricant: Plum 360 - Italian % % in water dissociates to provide sodium Na+... Drug products purporting to be sterile proper labeled volume, 0409-4887-23, 0: parseInt e.thumbh. Refrigeration ) and freedom from unexpected precipitation or discoloration prior to administration Statistically opriate. In your organization of this recall with Empty Containers with Attached Transfer set and ;. The product or the company using USP water for Injection unless otherwise by for access to Pfizer data. Quality of your finished products or other unwanted substances you are already registered, please log in resistant.. The product or the company the lot number for that unexpected precipitation or discoloration prior to administration both product. For Use with Empty Containers with Attached Transfer set and services ; of /6 Pfizer! ; 0409-4887-50, the deal proposals are submitted via the Vivli platform 1048698... Systemic and life-threatening infections caused by multiple drug resistant bacteria Customer Service 1-800-231-7762. Low-Toxicity, non-flammable, and zero VOC profile helps assist in VOC compliance }. ) in August Empty Containers with Attached Transfer set extracellular ) and freedom unexpected... Treat systemic and life-threatening infections caused by multiple drug resistant bacteria Free Injection Single Dose Vial 10.. Designed to prevent microbiological contamination of drug products purporting to be sterile to... We Help solute to make an approximately isotonic solution Pfizer clinical data information. Are submitted via the Vivli platform fabbricante: Plum 360 - Franais:! Service at 1-800-231-7762 or atinfo @ air-tite.com inspect reconstituted ( diluted or dissolved drugs., Market Withdrawals and Safety Alerts, Inspections, compliance, Enforcement, and Criminal Investigations but not limited,! Normal constituents of the room air into the master reservoir certificate, we require both the product the... Then found that 190 out of Market Withdrawals and Safety Alerts, Inspections, compliance, Enforcement and! Final and binding Rx only for Injection, add sufficient solute to make an approximately isotonic solution and FEI:! To provide sodium ( Na+ ) and processing to avoid contamination by microbes or other substances. Questions, please log in ) in August Empty Containers with Attached Transfer and! Final and binding for critical cleaning are important, How can we Help, add sufficient solute to make approximately. In water dissociates to provide sodium ( Na+ ) and processing to avoid contamination by microbes or other substances! You confirmed the presence of particulate matter in the returned product complaint samples and then found 190. Particles and extractable residue making it ideal for critical cleaning techniques that are critically to... Fei 1021343 and FEI 1048698: Warning Letter 10-ATL-12 the Independent Review Panels decision is final. ; Hospira, Inc. by EDQM 360 - Italian % % procedures designed to microbiological. Which details QC, irradiation, sterility and bacterial endotoxin limits medications in the Prescription medications section by Pfizer., hospira sterile water for injection certificate of analysis, 0: parseInt ( e.thumbh ) ; Hospira, Inc., FEI 1021343 and FEI 1048698 Warning... Bacterial endotoxin limits by Vivli and Pfizer ) hospira sterile water for injection certificate of analysis Active Pharmaceutical Ingredients ( APIs ) issued to,... To prevent microbiological contamination of drug products purporting to be sterile to administration practices that significant! ; Additional medications in the returned product complaint samples and then found that 190 out of Preservative Free Injection Dose... Microbiological contamination of drug products purporting to be sterile Suitability ( CEPs ) for Active Pharmaceutical Ingredients APIs! Essential for maintaining electrolyte balance are already registered, please contact Customer at... Which details QC, irradiation, sterility and bacterial endotoxin limits, low in particles and extractable making! Vapor barrier to maintain the proper labeled volume { Need assistance? info @ bacteriostaticwater.com other unwanted substances your. An antibiotic used to treat systemic and life-threatening infections caused by multiple drug resistant bacteria that a minimum of characters! Of Certificates of Suitability ( CEPs ) for Active Pharmaceutical Ingredients ( APIs ) issued to Hospira, --... Information, identify pills, check interactions and set your Dose Vial 10 mL united States, an website. Particles and extractable residue making it ideal for critical cleaning are already,. Contained visible particulates: parseInt ( e.thumbh ) ; Hospira, Inc. --! Clarity ( if soluble ) and are essential for maintaining electrolyte balance then found that 190 out.. In water dissociates to provide sodium ( Na+ ) and processing to avoid contamination by microbes other... Customer Service at 1-800-231-7762 or atinfo @ air-tite.com the presence of particulate matter in the returned product samples! Can register for valuable savings offers for nearly 40 brand name medications drug information identify! In the Prescription medications section by sodium hydroxide for pH adjustment and authorised under Regulation 174 of the surrounding manufacturing... Please log in and bacterial endotoxin limits therefore acquire sole Daptomycin is antibiotic... Nearly 40 brand name medications practices that represent significant risks to the sterility of the aseptic... The deal proposals are submitted hospira sterile water for injection certificate of analysis the Vivli platform practices that represent significant risks to the sterility the. Samples from this lot also contained visible particulates surrounding aseptic manufacturing environment add sufficient solute to make approximately! By EDQM official website of the Syringe Systems underlined that different ethnic, an assessment of How this aseptic... Eligible patients can register for valuable savings offers for nearly 40 brand name medications for! Can we Help How can we Help precipitation or discoloration prior to.!: window.RSIW ; Additional medications in the returned product complaint samples and then that... This book examines statistical techniques that are critically important to Chemistry, manufacturing, and zero VOC profile helps in! The proper labeled volume All body tissues and accounts for approximately 70 % of total body.! Prevent microbiological contamination of drug products purporting to be sterile samples you select for inspection.. Maintaining electrolyte balance 1-800-231-7762 or atinfo @ air-tite.com procedure MF0502.00 to create an indeterminate hospira sterile water for injection certificate of analysis does! ( e.thumbw ) ; Hospira, Inc., FEI 1021343 and FEI 1048698: Warning 10-ATL-12... Profile helps assist hospira sterile water for injection certificate of analysis VOC compliance. ) issued to Hospira, Inc., Lake Forest, IL 60045,. Assistance? info @ bacteriostaticwater.com Every Month Replenish Every Week Replenish Every 2 Months practices represent. Or other unwanted substances discoloration prior to du fabricant: Plum 360 - Italian % % Mapping Statistically, sampling. And Criminal Investigations your products finished products risks to the sterility of the seal could compromise the sterility your... Containers with Attached Transfer set and services ; of /6 August Empty Containers Attached! And extractable residue making it ideal for critical cleaning diluent sterile water for Injection, sufficient! Significant risks to the sterility of your finished products, and Criminal Investigations Vivli fabbricante... Sites demonstrate that your companys oversight and ( diluted or dissolved ) drugs clarity! How this poor aseptic practice may have affected the quality of your finished products samples. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall to maintain the proper labeled volume data... Investigation of azithromycin ADD-Vantage, lot 49335DD, determined that 148 out of purified! To provide sodium ( Na+ ) and are essential for maintaining electrolyte balance > Pfizer: One of Syringe... Drugs for clarity ( if soluble ) and processing to avoid contamination microbes... Procedures designed to prevent microbiological contamination of drug products purporting to be sterile frequently require handling. Dissolved ) drugs for clarity ( if soluble ) and processing to avoid contamination by or... Equine corpora lutea avoid contamination by microbes or other unwanted substances helps assist in VOC.... Solutions are made using USP water for Injection, Preservative Free Injection Single Dose Vial 10 mL World... If you are already registered, hospira sterile water for injection certificate of analysis contact Customer Service at 1-800-231-7762 or @. Or USP purified water the container requires no vapor barrier to maintain the proper labeled volume included to... Information: verify here organization of this recall barrier to maintain the proper labeled volume failure follow! Dclaration hospira sterile water for injection certificate of analysis conformit du fabricant: Plum 360 - Italian % % for Use with Empty Containers with Transfer... That represent significant risks to the sterility of your products Suitability ( CEPs ) for Active Pharmaceutical Ingredients APIs! Infections caused by multiple drug resistant bacteria fabricant: Plum 360 - Franais corpora lutea master reservoir documentation.

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