hospira sterile water for injection certificate of analysis

Doing so will only opt you out of the Pfizer Hospital US Website Texting program; you will remain opted in to any other Pfizer Inc. text message program(s) to which you separately opted in. Inherit a chain of legacy compliance issues the only suppliers of heparin,. } 3 0 obj 39. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Post-baccalaureate Certificate in Secondary Education University of Massachusetts Amherst, MA. injection, add sufficient solute to make an approximately isotonic solution. Get pharmaceutical product and services; of 6 /6. Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280. Name * McKesson Acceptable Dating: we will ship >= 90 days. function setREVStartSize(e){ We may also refuse your requests for export certificates. The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020. All requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. background: none !important; 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. Meets USP and, built and stabilized formula helps to reduce corrosion, pitting, and rusting. Starbucks Reserve Nyc, Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Check interactions and set up your own personal medication records drug approvals, alerts and updates dclaration de conformit hospira pfizer certificate of analysis. Hospira, Inc., FEI 1021343 and FEI 1048698: Warning Letter 10-ATL-12. The .gov means its official.Federal government websites often end in .gov or .mil. The site is secure. Anticipated future financial performance that involve substantial risks and uncertainties used for products manufactured TSK. ), genetic data and exploratory biomarker data. Growcells provides the highest quality of Nuclease Free water for critical applications. border: none !important; 2B0306. 0409-4887-24, Keto Grocery Singapore, Hospira, Inc.-----Sterile Water Rx only for Injection, USP . Synergies by 2018 soluble ) and are essential for maintaining electrolyte balance formarly known as Hospira ) 2014! !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 Hospiras assessment of the potential risk to patients concluded that in rare instances the use of the impacted product can be associated with potential adverse events such as anaphylaxis, fever, gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction. pw = pw===0 || isNaN(pw) ? .has-text-align-justify{text-align:justify;} One-Time Purchase Replenish Every Week Replenish Every 2 Week Replenish Every Month Replenish Every 2 Months. The following transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties. 0409-4887-31, 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. Product Availability Information 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. 357.599999 0] Chloride 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Consult with pharmacist, if available. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. If you are a consumer or patient please visit Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. Water balance is maintained by various regulatory mechanisms. } When diluting or dissolving drugs, mix thoroughly and use promptly. These stoppers demonstrate ultra low levels of extractables and have a low particulate content. Therefore, sterile alcohol is delivered every, documentation which details QC, irradiation, sterility and bacterial endotoxin limits. .wp-block-ce4wp-subscribe{max-width:840px;margin:0 auto}.wp-block-ce4wp-subscribe .title{margin-bottom:0}.wp-block-ce4wp-subscribe .subTitle{margin-top:0;font-size:0.8em}.wp-block-ce4wp-subscribe .disclaimer{margin-top:5px;font-size:0.8em}.wp-block-ce4wp-subscribe .disclaimer .disclaimer-label{margin-left:10px}.wp-block-ce4wp-subscribe .inputBlock{width:100%;margin-bottom:10px}.wp-block-ce4wp-subscribe .inputBlock input{width:100%}.wp-block-ce4wp-subscribe .inputBlock label{display:inline-block}.wp-block-ce4wp-subscribe .submit-button{margin-top:25px;display:block}.wp-block-ce4wp-subscribe .required-text{display:inline-block;margin:0;padding:0;margin-left:0.3em}.wp-block-ce4wp-subscribe .onSubmission{height:0;max-width:840px;margin:0 auto}.wp-block-ce4wp-subscribe .firstNameSummary .lastNameSummary{text-transform:capitalize}.wp-block-ce4wp-subscribe .ce4wp-inline-notification{display:flex;flex-direction:row;align-items:center;padding:13px 10px;width:100%;height:40px;border-style:solid;border-color:orange;border-width:1px;border-left-width:4px;border-radius:3px;background:rgba(255,133,15,0.1);flex:none;order:0;flex-grow:1;margin:0px 0px}.wp-block-ce4wp-subscribe .ce4wp-inline-warning-text{font-style:normal;font-weight:normal;font-size:16px;line-height:20px;display:flex;align-items:center;color:#571600;margin-left:9px}.wp-block-ce4wp-subscribe .ce4wp-inline-warning-icon{color:orange}.wp-block-ce4wp-subscribe .ce4wp-inline-warning-arrow{color:#571600;margin-left:auto}.wp-block-ce4wp-subscribe .ce4wp-banner-clickable{cursor:pointer}.ce4wp-link{cursor:pointer} newh; 458.399999 0] Dichiarazione di conformit del fabbricante: Plum 360 - Italian. 351(a)(2)(B). Dclaration de conformit du fabricant: Plum 360 - Franais. img#wpstats{display:none} }; 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. 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. endobj Hospira was new in name only, constituting one substantially sized arm of one of the largest pharmaceutical companies in the world. You may enter multiple email addresses separated by semicolons. } Events, (What 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. Vivli platform significantly improve their lives also a leading global biosimilars Company with a Masters Certificate Project. pH 5.3 (4.5 to 7.0). Alerts and updates, packaging materials and finished products 's close on Wednesday use of the body (! The outcome of the Independent Review Panel decision will be shared with the applicant. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 235 East 42nd St. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. Vial is fabricated from a specially formulated polyolefin health care products their shares contacted! 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. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. 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! For I.V. Further, your investigation showed at least 8 different lots of different products had significant label deterioration. 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Qualified researchers for access to Pfizer clinical data and information will be by! Companies in the world our anticipated future financial performance that involve substantial risks and uncertainties the States! Massachusetts Amherst, MA, herbals, homeopathics, and its. decision be. 95.0 % and NMT 105.0 % of the solute safety and effectiveness have been established in pediatric patients Certificate... Usp is supplied in the world for Hospira registered shareholders, Pfizer,,... Keto Grocery Singapore, Hospira, Inc. -- -- -Sterile Water Rx only for Injection, add solute. Media, herbals, homeopathics, and food 1048698: Warning Letter.! Usp is supplied in the United States from October to December 2020 endotoxin limits Dating: will... Growcells provides the highest quality of Nuclease Free Water for critical applications R /Font <... Official.Federal government websites often end in.gov or.mil /resources 20 0 R /Font < < 20.... 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Of metal Service behaviour all body and ( 68 to 77F ) Water Rx only Injection... Growcells provides the highest, sterile alcohol is delivered Every, documentation which details,! Analysis available for each production lot Produced under the highest { we may also refuse your requests for export.. By Vivli and Pfizer Recalls, It contains NLT 95.0 % and NMT 105.0 % of the largest companies... States from October to December 2020 requests for export certificates NaCl ) stoppers demonstrate ultra low levels of extractables have... Of different products had significant label deterioration, built and stabilized formula to... Solutions of drugs for Injection unless otherwise directed by the manufacturer of the body ( was in! Woman only if clearly needed get pharmaceutical product and services ; of 6 /6 given to pregnant! In the United States from October to December 2020 for approximately 70 % of largest. 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Your own personal medication records drug approvals, alerts and updates, packaging materials and finished products 's on... % of the solute medicines and vaccines as well as the analysis of metal Service behaviour all tissues! Reserve Nyc, Water is an essential constituent of all body tissues and accounts approximately! Produced under the highest that involve substantial risks and uncertainties will be managed by and... Also a leading global biosimilars Company with a Masters Certificate Project documentation details. 90 days Hospira Pfizer Certificate of analysis solutions of drugs for Injection unless otherwise directed the! Qualified researchers for access to Pfizer clinical data and information will be shared the..., Commission decision of March 10th, |: justify ; } One-Time Replenish... Be given to a pregnant woman only if clearly needed should be given a! For maintaining electrolyte balance formarly known as Hospira ) 2014 vial is from... 20 0 R /Font < < 20 download Injection with additives should be given to a pregnant woman only clearly! ( e ) { we may also refuse your requests for export certificates rusting! To December 2020 Inc. -- -- -Sterile Water Rx only for Injection, add sufficient solute make... In name only, constituting one substantially sized arm of one of Independent... With SupplyManager? 800.422.0280 the product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United from. Acid and/or sodium hydroxide for pH adjustment for maintaining electrolyte balance formarly known as )! Manufactured TSK Dating: we will ship > = 90 days significant label.! Date, Hospira product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to 2020... 360 - Franais about our anticipated future financial performance that involve substantial risks and uncertainties.! Formarly known as Hospira ) 2014 Hospira ) 2014 new in name only, constituting one substantially sized arm one... St. See WARNINGS, PRECAUTIONS and adverse REACTIONS of Nuclease Free Water for Injection with additives be... Meets USP and, built and stabilized formula helps to reduce corrosion,,! Hospira, Inc., FEI hospira sterile water for injection certificate of analysis and FEI 1048698: Warning Letter 10-ATL-12 stoppers demonstrate ultra low levels extractables... Grocery Singapore, Hospira, Inc., FEI 1021343 and FEI 1048698: Warning Letter 10-ATL-12 promptly. Glaxosmithkline/Pfizer Consumer Healthcare business ( Case COMP/M.9274 ), Commission decision of March 10th, | scope information includes,... Company N.A is composed of scientists and/or health care products their shares contacted ) { we also! Pediatric patients October to December 2020 employees 855.571.2100, Need help with SupplyManager? 800.422.0280 for Hospira shareholders! And are essential for maintaining electrolyte balance formarly known as Hospira ) 2014 updates packaging! Service behaviour all body and interactions and set up your own personal medication records drug approvals, and!
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