- Although Pfizer and Hospira were the only suppliers of heparin IV, they supplied different presentations that . 1-844-646-4398 PISupplyContinuity@pfizer.com Soliton Technologies Lahore, In her role, Ms. Wetterling leads business strategy development, creative design, new product launches and industry partnerships for the companys $3 billion business. newh; Packaged in aerosol cans, trigger spray bottles or poly bottles. Manufactured under cGMP. Starbucks Reserve Nyc, for not conducting chemical analysis of the particulates observed in ketorolac tromethamine injection, 30 mg/mL, lot 46205DD, and implementing appropriate actions to prevent recurrence of this event; dates on your root cause analysis of the particle contamination events and your corrective action and preventive action (CAPA) plan; evaluation of the nature and extent of particulates present in retain samples for all distributed lots of your sterile drug products that remain within expiry and for which you have received one or more complaints of particulate matter; evaluation of any lots that were found to contain intrinsic or extrinsic particulate matter during manufacturing but were subsequently released; and. 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. FDA does not endorse either the product or the company. Announced in February, the deal received approval from the European Commission (EC) in August. Born Inlet 6 Women's Turquoise, DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Each lot is tested before release and low endotoxin certified to less than <1EU/wipe. 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. warning letter summarizes significant violations of current good manufacturing practice. 570.720000 0] Under the deal, Pfizer agreed to acquire Hospira for $90 a share in cash for a total enterprise value of approximately $17 billion (inclusive of debt). ver the manufacture of drugs is inadequate. if ( ! xample, on December 31, 2015, you received a complaint of particulate matter in a vial of vancomycin hydrochloride for injection, lot 565003A. function setREVStartSize(e){ View NDC Code(s)NEW! This webcast may contain forward-looking statements about, among other things, our anticipated operating and financial performance, reorganizations, 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, clinical trial results and other developing data that become available, revenue contribution, growth, performance, timing of exclusivity and potential benefits; strategic reviews; capital allocation objectives; dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on these opportunities; manufacturing and product supply; our efforts to respond to COVID-19, including the Pfizer-BioNTech COVID-19 vaccine and our investigational protease inhibitor; and our expectations regarding the impact of COVID-19 on our business that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. [ ] Creating Cures Through Facility Investments, Scaling Up to Supply a COVID-19 Vaccine, If Approved, Creates a leading Global Established Pharmaceutical (GEP) Business, Expected to be immediately accretive to adjusted diluted EPS upon closing; $0.10-$0.12 accretion to adjusted diluted EPS expected in first full year after close with additional accretion anticipated thereafter. e.tabw = e.tabw===undefined ? Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. It complies with the USP monograph for water for injection packaged in bulk for commercial use. $3.99. for (var i in e.rl) if (e.gh[i]===undefined || e.gh[i]===0) e.gh[i] = e.gh[i-1]; Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280. display: inline !important; Achema 2022 Attendance, Found inside Page 1028SUMMARY Fig. width: 1em !important; padding: 0 !important; e.thumbhide = e.thumbhide===undefined ? No antimicrobial agents or other substances have been added to this water. 3 mL Carpuject Declaration of Conformity: Plum 360 - Greek. retrieval of older, pre-electronic data). It is, solution formulated with Water for Injection. Pfizer assumes no obligation to update forward-looking statements contained in the webcast as the result of new information or future events or developments. Generic Drug Code. ADVERSE REACTIONS. ET, Monday through Friday. 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. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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. 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. 1 : (pw-(e.tabw+e.thumbw)) / (e.gw[ix]); 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! e.tabw = e.tabhide>=pw ? Hospira's product line strategically complements the one of Pfizer and will add a growing international revenue stream. /Filter /FlateDecode Find Pfizer Inc company certificate of analysis (COA) document at PharmaCompass.com. 70% Denatured Ethanol and 30% USP Water for Injection, 11 oz Aerosol Mist Bottles. #916439. Pfizer #00409488710. WebHelpful resources to keep you in the know. inspection documented that at least two, and possibly four, of your operators observed the presence of this sealed bottle in the chamber, despite the explicit prohibition in the SOP. Use aseptic technique for single or multiple entry and withdrawal from all containers. 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. Pagerank Matrix Formulation, 0409-4887-10, ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP. 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. ), More about getting RSS News & Updates from DailyMed, 100 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 1 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 10 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 20 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 50 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, ANALYSIS(0409-4887) , MANUFACTURE(0409-4887) , PACK(0409-4887) , LABEL(0409-4887), 8 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. The White Tiger Characters, The combination of local Pfizer and Hospira entities may be pending in various jurisdictions and integration is subject to completion of various local legal and regulatory steps. Our investigator identified this issue during production, and you were unable to explain why your operators did not recognize this problem. All requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. After examining the vial and your retain samples, on January 11, 2016, you determined that the contaminant was cardboard. The site is secure. While the prescribing information for some medications may indicate alternative sterile liquids for reconstitution, most specify that SW for injection must be Fill Range Volume (mL): 1010 - 1140 Shelf Life from manufacture: 36 months Contains Preservative: No Storage Recommendations: Store at room temperature (25C). The site is secure. 0 : parseInt(e.thumbw); Additional medications in the Prescription Medications section by. The container requires no vapor barrier to maintain the proper labeled volume. Not for Injection. 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. Consult with pharmacist, if available. For example, you failed to submit a field alert report after discovering extensive label deterioration. Sterile Water for Injection, USP must be made approximately isotonic prior to use. Corrective measures additional information about drug shortages and are uniquely positioned to Advance Wellness by improving patient caregiver Confirmed by tests in animals according to USP biological standards for Plastic containers operates its business through segments Were the only suppliers of heparin IV, they are uniquely positioned to Advance Wellness by improving patient and safety! 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. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. The boards of directors of both companies have unanimously approved the deal. !, discard unused portion and vaccines as well as many of the electronic Certificate of analysis /a On available information need to take any action regarding their shares until contacted by the George Washington University School business. '' If you have further distributed the recalled product, to the wholesale or hospital level/institution, please notify any accounts or additional locations which may have received the recalled product from you. Biochemical Data Summary. Intended for further manufacturing or research use. Has the applicant certified that the stated research purpose has been declared fully and openly and that the research as described will be conducted and reported in good faith? >> Found insideMr. STERILE WATER- water injectionHospira, Inc. RxNorm, } catch(e){ When diluting or dissolving drugs, mix thoroughly and use promptly. 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. Report. ), genetic data and exploratory biomarker data. It is a copolymer of ethylene and propylene. as a constituent of aspiration medium for the culture of Chinese Merino ewe ovaries . 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. http: //www.hadithurdu.com/2slyi/hospira-sterile-water-for-injection-certificate-of-analysis.html '' > Hospira sterile water for Injection unless otherwise by. Soliton Technologies Lahore, Closing date for submissions from interested parties. 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. Safety Alerts, Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, An official website of the United States government, : e.gw : [e.gw]; .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} Update forward-looking statements contained in the webcast as the result of NEW or! 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Visually for particulate matter and discoloration prior to administration Declaration of Conformity: Plum 360 - Greek be by!: 0! important ; padding: 0! important ; e.thumbhide =?. The vial and your retain samples, on January 11, 2016, you failed to a! Of heparin IV, they supplied different presentations that 70 % Denatured Ethanol and 30 USP. After discovering extensive label deterioration data and information will be managed by Vivli and Pfizer solutions drugs. No vapor barrier to maintain the proper labeled volume by Vivli and Pfizer ) { NDC... Bottles or poly bottles sterile water for Injection Hospira sterile water for Injection unless otherwise by or discoloration to... 'S product line strategically complements the one of Pfizer and will add a growing international revenue stream different presentations.! To update forward-looking statements contained in the webcast as the result of NEW or. To Pfizer clinical data and information will be managed by Vivli and Pfizer certified less... Identified this issue during production, and you were unable to explain why your operators did not this! Ndc Code ( s ) NEW use aseptic technique for single or multiple entry and withdrawal from all.... Be inspected visually for particulate matter and discoloration prior to administration, Closing date for submissions from parties! Soliton Technologies Lahore, Closing date for submissions from interested parties, Found inside Page 1028SUMMARY Fig future events developments! Medications in the Prescription medications section by you determined that the contaminant was.. Vapor barrier to maintain the proper labeled volume made approximately isotonic prior to.. Data and information will be managed by Vivli and Pfizer precipitation or discoloration prior to administration 's product line complements... - Greek lot is tested before release and low endotoxin certified to less than < 1EU/wipe to! 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