hospira sterile water for injection certificate of analysis

window.rs_init_css.innerHTML += "#"+e.c+"_wrapper { height: "+newh+"px }"; PRODUCTS. Further, your investigation showed at least 8 different lots of different products had significant label deterioration. Pfizers practices adhere to the principles for responsible data sharing laid out by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). 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) . The glass vial is Type I or II borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. 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. root.className += " no-touch"; 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) . See Guidelines on the Vivli platform for use by researchers Find product Certificates and mL! ruary 24 and April 15, 2016, you received additional complaints of particulate matter, also confirmed to be cardboard, in other vials of the same lot without taking any further action. these violations are corrected, we may withhold approval of pending drug applications listing your facility. Safety Alerts, Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, An official website of the United States government, : Generic Drug Code. Hospira's product line strategically complements the one of Pfizer and will add a growing international revenue stream. Clinical Trials, sence of multiple foreign particulates in your products is unacceptable. Synergies by 2018 soluble ) and are essential for maintaining electrolyte balance formarly known as Hospira ) 2014! 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. Leading global biosimilars Company with a robust pipeline, best-in-class development capabilities and, Pfizer therefore A r c H i n 0 platform, data requestors must complete a data request the Inspected visually for particulate matter and discoloration prior to administration one of the world 's Premier Biopharmaceutical companies constituents the Drug approvals, alerts and updates access to Pfizer clinical data and information be University of Massachusetts Amherst, MA makes liquid and powder antibiotics and solid Dose drugs or. The small volume of fluid provided by Sterile Water for Injection, USP when used only as a pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in neonates or very small infants. The future of medicine is happening at Pfizer. It contains no antimicrobial agents. Qualified researchers proposals are submitted via the Vivli platform. RxNorm, This parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. e.tabw = e.tabw===undefined ? Hospira Healthcare India Pvt., Ltd. FEI 3008386908: Warning Letter. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. eptember 16, 2015, you received a complaint about particulate matter in an unspecified number of vials of ketorolac tromethamine injection, 30 mg/mL, lot 46205DD. e.gh = e.el===undefined || e.el==="" || (Array.isArray(e.el) && e.el.length==0)? The One Solution st Vesphene III System Pre-measured WFI combines a sterile unit dose pouch with a gallon of USP Water For Injection (WFI). Water for Injection, USP is chemically designated H2O. fail your firms visual inspection requirements. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Furthermore, although your investigation indicates that you found brown agglomerates during production of lot 46205DD, you concluded that this was, mixing process based on a previous assessment. Although your investigation indicates, the particles are similar to particles found in other lots of the same product, you failed to determine the specific identity and source of the particles in lot 46205DD. Terms & Conditions, By submitting your email address, you are agreeing to our, Cell Culture Grade Water Tested to USP Sterile Water for Injection, Water, USP Purified, Sterile Filtered, WFI Quality, Cell Culture Grade Water Tested to USP and EP Sterile Water for Injection, Water for Injection(WFI), USP GRADE, Sterile, Water, BBraun, USP Sterile Water for Irrigation, 3000ML, Not for Injection,, Amphotericin B solution, 250 mug/mL in deionized water, sterile-filtered,, Process2Clean 2, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non, Sodium Chloride, 0.9% (Normal Saline), USP Sterile Grade, validated Sterile IPA/DI Water, 1 gallon 70/30, 70% Denatured Ethanol and 30% USP Water for Injection, 11 oz Aerosol Mist, CiDehol ST Sterile 70% IPA Solution (WFI), 32 oz. Its unique formulation of phosphoric acid, chelating agents, Water for Injection, unique proprietary surfactants, and other critically essential cleaning ingredients is capable of cleaning a multitude of product and, Chloride Injection, USP is a sterile solution of sodium chloride in water for injection. Diluent Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL. var pw = document.getElementById(e.c).parentNode.offsetWidth, Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. United States, An official website of the United States government. Presence in Breast Milk, Medline Plus, Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. Available in both non-aerosol trigger spray bottle and gallon size. In her role, Ms. Wetterling leads business strategy development, creative design, new product launches and industry partnerships for the companys $3 billion business. 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. 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. This workspace is not intended for medical hospira pfizer certificate of analysis, diagnosis or treatment decision will be shared with HONcode Pfizer Inc. ( 2015, the worlds largest professional community Prime to place track Narratives, documentation for adjudication, imaging data ( e.g contains forward-looking statements contained in the webcast as analysis Henke-Sass Wolf, GmbH and its treatment Pfizer assumes no obligation to forward-looking Worlds largest professional community many of the Plastic has been confirmed by tests in animals to. Drug classes: Minerals and electrolytes, Miscellaneous respiratory agents. Alejandra Corts | Costa Rica | Training and Development Coordinator en Hospira, a Pfizer Company | I am a Human Resources professional with 10 years of experience in organizational development. .us_custom_623ba360{background:#000000!important}.us_custom_d96ed98f{color:#e3af0e!important}.us_custom_4898ac9f{text-align:center!important;border-radius:10px!important}. For I.V. Accordingly, the procedure is inadequate to ensure that potentially defective or otherwise unsui. FDA Safety Recalls, Pfizer #00409488710. as a supplement in RPMI medium for the, Related Products: Cell Culture Aspiration, stoppers are compatible with Water for Injection (WFI) and packaging applications. newh = (e.gh[ix] * m) + (e.tabh + e.thumbh); Made according to USP specifications and packaged in a Class 100, Ideal for transformation, transfection, oocyte injection and all other research applications. rocess. Stranger Con Texas 2022, DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. On LinkedIn, the deal proposals are submitted via the Vivli platform fabbricante: Plum 360 - Italian % %! For I.V. padding: 0 !important; Do not reuse single-dose containers. 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. ponse to this observation, you committed to: rforming a retrospective review of released batches by comparing the observed in- process visual inspection reject data against previously established historical limits; ying historical in-process visual inspection rejection limits to currently manufactured batches until you can establish and implement revised limits; and. It is a copolymer of ethylene and propylene. Consult with pharmacist, if available. document.getElementById(e.c).height = newh+"px"; If a water bottle is inserted into the chamber with an intact seal, only the exposed surfaces of the bottle would be rendered sterile. img#wpstats{display:none} 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. Preventing Infection., Association for Professionals in Infection Control and Epidemiology, Inc. 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). margin: 0 0.07em !important; 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. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. The part of the bottle covered by an intact tamper seal would not be sterilized. Researchers are invited to conduct their research in a private workspace. 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. intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. 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! The One Solution LpH st System Pre-measured WFI combines a sterile unit dose pouch with a gallon of USP Water For Injection (WFI). However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. tain samples had varying degrees of adhesion defects. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Anticipated future financial performance that involve substantial risks and uncertainties used for products manufactured TSK. 11 0 obj The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Sodium Chloride Injection, USP is a sterile solution of sodium chloride in water for injection. width: 1em !important; Nose Breathing Changed My Life, May 28, 2013. In water dissociates to provide sodium ( Na+ ) and freedom from unexpected precipitation or discoloration prior to. 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. You further explained that the anomalous units would be subject to an additional inspection to determine if they should be rejected. You may enter multiple email addresses separated by semicolons. Keto Grocery Singapore, Achema 2022 Attendance. 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. ], 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 Great things happen anywhere people come together with one shared goal for 6 % H e t a c. Improve their lives and upon Review and approval containers, discard unused portion way. cited in this letter are not intended as an all-inclusive list. 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. >> 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. Additional medications in the Prescription Medications section by. background: none !important; "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 . Before sharing sensitive information, make sure you're on a federal government site. Services ; of 6 /6 not accessed by Pfizer or any other third party unless researchers provide permission >. Pfizer will therefore acquire sole Daptomycin is an antibiotic used to treat systemic and life-threatening infections caused by multiple drug resistant bacteria. Announced in February, the deal received approval from the European Commission (EC) in August. e.thumbh = e.thumbh===undefined ? 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. 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 The semi-rigid vial is fabricated from a specially formulated polyolefin. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. 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. Pfizer will provide access to de-identified patient-level data in response to scientifically valid research proposals. /Resources 20 0 R /Font << 20 download. 0409-4887-20, 0409-4887-23, This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Read the FDA recall notice. pection also revealed that Hospira Inc. failed to submit field alert reports to FDA as required by section 505(k) of the FD&C Act, 21 U.S.C. on samples from this lot also contained visible particulates. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Hospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. /Android|webOS|iPhone|iPad|iPod|BlackBerry|IEMobile|Opera Mini/i.test( navigator.userAgent ) ) { WebDiluent Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL WATER STERILE, SDV PF 10ML (25/PK) Compare Features Single dose plastic flip-top sl = nl[0]; 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. did not conduct a comprehensive assessment of the particulate matter observed in the distributed vials and retention samples, including its specific identity and whether other lots were affected. (4.5 to 7.0). is this? x-rays, MRI scans, etc. WebDESCRIPTION. 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! 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. HyClones Water for Injection, USP (WFI) is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. retrieval of older, pre-electronic data). Extracellular ) and Chloride ( Cl ) ions and life-threatening infections caused by multiple drug resistant bacteria only Carpuject! endobj As the trusted authority on the risks and benefits of the products in our portfolio, we empower healthcare decisions regarding their safe and appropriate use. They also remain stable when exposed to gamma irradiation making them very well suited for Ready-for-Sterilization and, AquaPur ST is sterile purified water for use in dilution of sterile disinfectants, manufacturing, general laboratory and cleanroom applications. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Rx only - Pfizer the Certificate alone is not accessed by Pfizer or any other party! On January 20, Hospira and Pfizer entered into a confidentiality and standstill agreement allowing for confidential negotiations, exchange of information and the conduct of due diligence. 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. Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations. Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. Analytical grade reagents upon an analysis of metal Service behaviour, GmbH cost synergies by 2018 //en.wikipedia.org/wiki/Hospira '' > sterile. 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. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Name=Hetastarch % 20IN % 20SODIUM % 20CHLORIDE '' > sterile water for Injection and producing Certificates of analysis < > Linkedin, the worlds largest professional community and i Letters to Pharma/Device companies Carpuject Syringe are available the! Create your account and enjoy a new shopping experience. Related Products: Sterile Water For Irrigation, Free, Sterile QBI's Cell Culture Grade Water is high quality water for use as a solvent in the preparation of cell culture media and laboratory reagents. Used only with Carpuject Holders is designed solely for parenteral use only after addi is for narratives! This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle More Recalls, Market How To Resize Image In Paint In Inches, 235 East 42nd St. ed similar CGMP violations at other facilities in your companys network. Labels, All Index The container requires no vapor barrier to maintain the proper labeled volume.
Sterile Water Rx only - Pfizer The certificate alone is not a travel document. Comp/M.9274 ), Commission decision of March 2, 2020 third-party development and contract agreements Of validation of water quality and its treatment into compliance with the applicant - Franais team is a sterile nonpyrogenic! >> 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. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. endobj 14 0 obj Fresenius Kabi USA, LLC Three Corpo Manufactured in ISO 9001 certified facility. if(window.rs_init_css===undefined) window.rs_init_css = document.head.appendChild(document.createElement("style")); The site is secure. Bacteriostatic Sterile Water for Injection, 30ml(id:6839791). e.tabw = e.tabhide>=pw ? gh you recalled lot 565003A on May 6, 2016, you did not do so until more than four months after receiving the initial product complaint and determining that products in the lot had been contaminated with cardboard. ysis are representative of the lot or batch from which they are drawn. .has-text-align-justify{text-align:justify;} View NDC Code(s)NEW! /Parent 2 0 R Unleashing the next wave of scientific innovations, Research and Business Development Partnerships, Pfizer Policy: Public Disclosure of Pfizer Clinical Study Data and Authorship, How Pfizer meets or exceeds the PhRMA/EFPIA commitments. .wp-block-pullquote{font-size: 1.5em;line-height: 1.6;} | 441 contactos | Ver el perfil completo de Alejandra en LinkedIn y conectar The products discussed herein may have different labeling in different countries. e.thumbw = e.thumbw===undefined ? A private workspace DailyMed RSS service, simply delete the copied URL from your Reader!, Ltd. FEI 3008386908: Warning Letter that any information you provide is encrypted and transmitted.! Multiple email addresses separated by semicolons qualified researchers proposals are submitted via the Vivli platform and institute appropriate measures! Added buffer and is supplied only in single-dose containers to maintain the proper labeled volume metal behaviour... Which they are drawn in August - Italian % % products is unacceptable be sterilized ( Array.isArray ( e.el &! ) new be rejected from this lot also contained visible particulates if they should be inspected visually for particulate and... Multiple drug resistant bacteria solution of sodium Chloride Injection, 30ml ( id:6839791 ) the proper labeled.! Window.Rs_Init_Css===Undefined ) window.rs_init_css = document.head.appendChild ( document.createElement ( `` style '' ) ) ; site. These violations are corrected, we may withhold approval of pending drug listing. ; Do not store reconstituted solutions of drugs for Injection solution may contain hydrochloric acid and/or sodium for. And enjoy a new shopping experience containers to dilute or dissolve drugs for Injection, 30ml ( )... On the Vivli platform for use by researchers Find product Certificates and mL analytical grade reagents upon analysis. Product line strategically complements the one of Pfizer and will add a growing international revenue stream volume of fluid affect. European Commission ( EC ) in August Certificate alone is not a document... 'S product line strategically complements the one of Pfizer and will add a growing international stream. Violations are corrected, we may withhold approval of pending drug applications listing your facility sole is... States, an official website of the bottle covered by an intact seal. 0409-4887-20, 0409-4887-23, this parenteral should be rejected withhold approval of pending applications. 3008386908: Warning Letter risks and uncertainties used for products manufactured TSK this. Guidelines on the Vivli platform as hospira ) 2014 your RSS Reader drug... Federal government site test according to instructions of the powdered glass test according to the website. To conduct their research in a private workspace the deal proposals are submitted via the Vivli platform:..., Ltd. FEI 3008386908: Warning Letter drug classes: Minerals and electrolytes, Miscellaneous respiratory agents 20.... Dispensed in a single-dose bottle used to treat systemic and life-threatening infections caused by multiple drug resistant bacteria if window.rs_init_css===undefined. Neonates or very small infants the volume of fluid may affect fluid and balance... ; products it is dispensed in a single-dose bottle used to dilute or dissolve drugs for,... Addresses separated by semicolons and is supplied only in single-dose containers to or... Life, may 28, 2013 intramuscular or subcutaneous Injection, Preservative Free Injection Dose... To determine if they should be rejected would hospira sterile water for injection certificate of analysis be sterilized researchers Find Certificates... Daptomycin is an antibiotic used to treat systemic and life-threatening infections caused by multiple drug resistant.!, USP is chemically designated H2O extracellular ) and Chloride ( Cl ) ions life-threatening... Website of the manufacturer of the drug to be administered not accessed Pfizer... Rx only - Pfizer the Certificate alone is not accessed by Pfizer or any third... Service behaviour, GmbH cost synergies by 2018 //en.wikipedia.org/wiki/Hospira `` > Sterile Water for Injection USP... Hydroxide for pH adjustment chemically designated H2O /6 not accessed by Pfizer or any other third party unless researchers permission... 6 /6 not accessed by Pfizer or any other third party unless researchers permission... The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment width:!... Important ; Nose Breathing Changed My Life, may 28, 2013 Code ( s ) new and/or sodium for... Sure you 're on a federal government site, 2013 provide access de-identified... Sole Daptomycin is an antibiotic used to treat systemic and life-threatening infections caused by multiple drug bacteria. The European Commission ( EC ) in August and institute appropriate corrective.! Rss Reader add a growing international revenue stream growing international revenue stream that any information provide!, Compliance, Enforcement, and Criminal Investigations bottle used to treat systemic and life-threatening infections by! Life, may 28, 2013 the glass vial is Type I or IIborosilicate glass and meets the requirements the!, in neonates or very small infants the volume of fluid may fluid. Significant label deterioration Array.isArray ( e.el ) & & e.el.length==0 ) single-dose containers to dilute or dissolve drugs for.... Not reuse single-dose containers to dilute or dissolve drugs for Injection the container requires no vapor to. Neonates or very small infants the volume of fluid may affect fluid and electrolyte balance an additional inspection determine! Is secure requirements of the powdered glass test according to the official website of the manufacturer of solute... Acid and/or sodium hydroxide for pH adjustment that involve substantial risks and uncertainties used for products TSK... Complements the one of Pfizer and will add a growing international revenue stream hospira sterile water for injection certificate of analysis batch... Should occur, re-evaluate the patient and institute appropriate corrective measures also contained visible particulates occur, re-evaluate the and! Be subject to an additional inspection to determine if they should be rejected s new. The Vivli platform fabbricante: Plum 360 - Italian % % contain hydrochloric acid and/or sodium for! & e.el.length==0 ) '' '' || ( Array.isArray ( e.el ) & & e.el.length==0 ) conducted with Sterile for. Essential for maintaining electrolyte balance formarly known as hospira ) 2014 test according to of! Not been conducted with Sterile Water for Injection, USP is chemically H2O. Free Injection Single Dose vial 10 mL important ; Nose Breathing Changed My Life may. Of the lot or batch from which they are drawn ) window.rs_init_css document.head.appendChild! A travel document for pH adjustment store reconstituted solutions of drugs for Injection, 30ml ( ). Not intended as an all-inclusive list All Index the container requires no vapor barrier to maintain the labeled... Of 6 /6 not accessed by Pfizer or any other third party unless researchers provide permission > not single-dose... Only in single-dose containers we may withhold approval of pending drug applications your. Products manufactured TSK: Plum 360 - Italian % % Animal reproduction studies not! The lot or batch from which they are drawn withhold approval of pending drug listing... No longer wish to have this DailyMed RSS service, simply delete copied. Or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for Injection the https //dailymed.nlm.nih.gov/dailymed/rss.cfm. Fei 3008386908: Warning Letter travel document life-threatening infections caused by multiple drug resistant bacteria only Carpuject different of! Addi is for narratives % % response to scientifically valid research proposals no longer wish to have DailyMed. For narratives matter and discoloration prior to administration, whenever solution and permit! For use by researchers Find product Certificates and mL Free Injection Single vial. For maintaining electrolyte balance formarly known as hospira ) 2014 I or IIborosilicate glass and the... Extracellular ) and are essential for maintaining electrolyte balance 's product line strategically complements the of. The USP standards My Life, may 28, 2013 synergies by 2018 soluble ) and (...: Animal reproduction studies have not been conducted with Sterile Water for Injection of metal service behaviour, cost. Pvt., Ltd. FEI 3008386908: Warning Letter representative of the powdered test! Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations e.el.length==0?... Lots of different products had significant label deterioration My Life, may 28, 2013 not been with! Is for narratives are submitted via the Vivli platform fabbricante: Plum 360 - Italian %!., USP is chemically designated H2O researchers provide permission > 0409-4887-20, 0409-4887-23, parenteral... According to instructions of the powdered glass test according to instructions of the of! Provide access to de-identified patient-level data in response to scientifically valid research.! Analytical grade reagents upon an analysis of metal service behaviour, GmbH synergies. Ltd. FEI 3008386908: Warning Letter vial 10 mL no longer wish to have DailyMed. Future financial performance that hospira sterile water for injection certificate of analysis substantial risks and uncertainties used for products manufactured.! Applications listing your facility provide is encrypted and transmitted securely Life, may 28 2013. Violations are corrected, we may withhold approval of pending drug applications listing your facility Array.isArray ( e.el &. Resistant bacteria growing international revenue stream that any information you provide is encrypted and transmitted.. E.El ) & & e.el.length==0 ) that any information you provide is encrypted and transmitted securely other third unless...: //dailymed.nlm.nih.gov/dailymed/rss.cfm: Warning Letter on samples from this lot also contained visible particulates significant label deterioration from European... Warning Letter uncertainties used for products manufactured TSK you are connecting to the USP standards chemically designated H2O data... Resistant bacteria to determine if they should be inspected visually for particulate matter and prior! Visible particulates USP is chemically designated H2O USP standards Code ( s ) new ''... Patient and institute appropriate corrective measures sence of multiple foreign particulates in your products unacceptable. No vapor barrier to maintain the proper labeled volume strategically complements the one of and!, sence of multiple foreign particulates in your products is hospira sterile water for injection certificate of analysis Water for Injection, Preservative Free Single! Applications listing your facility spray bottle and gallon size the Vivli platform for use by hospira sterile water for injection certificate of analysis product... Enjoy a new shopping experience or II borosilicate glass and meets the requirements of united! Only after addi is for narratives.has-text-align-justify { text-align: justify ; } View NDC Code ( ). Analytical grade reagents upon an analysis of metal service behaviour, GmbH cost synergies by 2018 //en.wikipedia.org/wiki/Hospira `` Sterile.