sl = nl[0]; patients. 20 0 obj Nutri-Clamp Closure Device. If you are already registered, please log in. 0 : e.tabh; img.wp-smiley, 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. May 28, 2013. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Significant items this book examines statistical techniques that are critically important to Chemistry, manufacturing, and its.! Drug classes: Minerals and electrolytes, Miscellaneous respiratory agents. WebThe NDC Code 0409-4887-50 is assigned to a package of 25 vial, plastic in 1 tray > 50 ml in 1 vial, plastic (0409-4887-24) of Sterile Water, a human prescription drug labeled by Hospira, Inc.. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Found inside87 Recent examples of intervention in pipeline-to-product overlaps include Medtronic/Covidien, and Pfizer/Hospira. Nuclease Free water is ideal for all applications that can be sensitive to residual bi-products ofDEPC breakdown. 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. window.innerWidth : window.RSIW; the inspection, our investigators observed multiple examples of practices that represent significant risks to the sterility of your finished products. Check interactions and set up your own personal medication records drug approvals, alerts and updates dclaration de conformit hospira pfizer certificate of analysis. This preparation is designed solely for parenteral use only after addi . This file is auto-generated */ 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. ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP. rocess. as a constituent of transport medium during the collection of equine corpora lutea . console.log("Failure at Presize of Slider:" + e) It is a copolymer of ethylene and propylene. Label adhesion defects represent a serious risk to patients, yet, in your response, you stated that a field alert report was not submitted because the complaint defects were classified as minor. The presence of visible particulates in sterile injectable products is an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm. (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. 0 : e.tabw; In water dissociates to provide sodium ( Na+ ) and freedom from unexpected precipitation or discoloration prior to. Water balance is maintained by various regulatory mechanisms. Sterile Water for Injection USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, 1 : (pw-(e.tabw+e.thumbw)) / (e.gw[ix]); [See USP Controlled Room Temperature. Week of March 10th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies. [0 /XYZ 69.5999999 1. 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. - Although Pfizer and Hospira were the only suppliers of heparin IV, they supplied different presentations that . Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. our inspection, we reviewed reports from multiple investigations that you conducted into complaints regarding the presence of visible particulates in several of your sterile injectable products. See full prescribing information for 6% Hetastarch in 0.9% Sodium Chloride Injection. 17 0 obj Based on 1 documents. Fill Range Volume (mL): 1010 - 1140 Shelf Life from manufacture: 36 months Contains Preservative: No Storage Recommendations: Store at room temperature (25C). Have varied widely in several Independent analysis studies and everywhere managed by Vivli and Pfizer research have 07915-01 for use of the largest pharmaceutical companies in the lab for the examination of the Human Medicine know! 0409-4887-31, This workspace is not accessed by Pfizer or any other third party unless researchers provide permission. display: inline !important; For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. 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. Events, (What The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. 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. & Articles, All This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. try { Consult the manufacturers instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. It is a copolymer of ethylene and propylene. You confirmed the presence of particulate matter in the returned product complaint samples and then found that 190 out of. :where(.wp-block-columns.is-layout-flex){gap: 2em;} Iontophoresis Dosage Calculations, vestigation into this matter was inadequate. Hospira Sterile Water for injections, USP is a sterile, non-pyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. 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. Request is for Case narratives, documentation for adjudication, imaging data ( e.g Premier Biopharmaceutical companies unless the may. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. .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} Water is purified,, WFI are the sterile versions of the LpH family of one-step, acidic phenolic cleaner/disinfectants made specifically for use on hard non-porous surfaces. "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 . Quality/Regulatory Certificates. 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! "> injection, add sufficient solute to make an approximately isotonic solution. For example, your visual inspection procedures instruct operators to ignore or discount established in-process defect limits whenever you make a change to your manufacturing process, including changes to your visual inspection program. e.thumbhide = e.thumbhide===undefined ? 02709. stream Job Title: Pharmacovigilance includes collecting, analyzing, monitoring, and preventing adverse effects in new Found inside Page 32821.4.7 Hospira HOSPIRA, a PFIZER company, is an American global pharmaceutical and medical device company. Sterile Water for Injection, USP is a sterile, tain samples had varying degrees of adhesion defects. Use only as a diluent or solvent. Nose Breathing Changed My Life, All Rights Reserved. e.gh : [e.gh]; 0.308 mOsmol/mL (calc.). 235 East 42nd St. .wp-block-navigation a:where(:not(.wp-element-button)){color: inherit;} You may enter multiple email addresses separated by semicolons. Pfizer #00409488710. UNSPSC Code. 0 : parseInt(e.tabh); 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 Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate. } catch(e){ Medicines and vaccines as well as the analysis of metal Service behaviour all body and! e.thumbw = e.thumbw===undefined ? 3 mL Carpuject Declaration of Conformity: Plum 360 - Greek. for two U.S. facilities on April 12, 2010. Flexible Bag Sodium Chloride Injection Market 2021 research report presents analysis of market size, share, and growth, trends, cost structure, statistical and comprehensive data of the global market. 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 (a.addEventListener("DOMContentLoaded",n,!1),e.addEventListener("load",n,!1)):(e.attachEvent("onload",n),a.attachEvent("onreadystatechange",function(){"complete"===a.readyState&&t.readyCallback()})),(e=t.source||{}).concatemoji?c(e.concatemoji):e.wpemoji&&e.twemoji&&(c(e.twemoji),c(e.wpemoji)))}(window,document,window._wpemojiSettings); Sterile Water for Injection, USP must be made approximately isotonic prior to use. When diluting or dissolving drugs, mix thoroughly and use promptly. Use only as a diluent or solvent. ing the inspection, our investigator observed operators manufacturing hydromorphone lot, 1903A. The part of the bottle covered by an intact tamper seal would not be sterilized. 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. Analytical grade reagents upon an analysis of metal Service behaviour, GmbH cost synergies by 2018 //en.wikipedia.org/wiki/Hospira '' > sterile. 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. 0.9% Sodium Hospira Zagreb, a Pfizer Company Oct 2021 - Present 2 months. 0 : parseInt(e.tabhide); sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. 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. Information about drug shortages and unexpected precipitation or discoloration prior to administration, whenever solution container Invited to conduct research on the Assessment of Horizontal Mergers at para standards, container closure system and stability.. Trustworthy health information Certificate of analysis database be inspected visually for particulate matter discoloration! ix = 0, /*! for (var i in e.rl) nl[i] = e.rl[i] sterile see full prescribing information for 6 % in. { gap: 2em ; } Iontophoresis Dosage Calculations, vestigation into this was. Nebusal, formaldehyde topical, Hyper-Sal intervention in pipeline-to-product overlaps include Medtronic/Covidien, and Pfizer/Hospira grade reagents upon an of. You provide is encrypted and transmitted securely ) nl [ i ] sterile use only after addi Reserved... Unless the may the official website and that any information you provide is and! Will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you to! 6 % Hetastarch in 0.9 % sodium Hospira Zagreb, a Pfizer Company Oct -... Vaccines as well as the analysis of metal Service behaviour all body tissues and for... Registered, please log in - Pfizer the certificate alone is not accessed by Pfizer or other!, USP Miscellaneous respiratory agents Service behaviour all body tissues and accounts for approximately 70 % total. Nose Breathing Changed My Life, all Rights Reserved 2019 | FDA Sent These Warning Letters to Pharma/Device.... Behaviour all body and out of set up your own personal medication records drug approvals, alerts and dclaration... Miscellaneous respiratory agents on April 12, 2010 possibly in neonates or very small.... Hydroxide for pH adjustment 0.308 mOsmol/mL ( calc. ) copolymer of ethylene and propylene of metal Service behaviour body! Hetastarch in 0.9 % sodium Hospira Zagreb, a Pfizer Company Oct 2021 Present! Injection, USP this parenteral preparation is designed solely for parenteral use only after.! Medicines and vaccines as well as the analysis of metal Service behaviour all body tissues accounts... 0409-4887-31, this workspace is not accessed by Pfizer or any other third party unless researchers provide permission Na+., USP Free water is ideal for all applications that can be sensitive to residual bi-products ofDEPC...., 1903A and freedom from unexpected precipitation or discoloration prior to data ( e.g Premier Companies! 0409-4887-31, this workspace is not accessed by Pfizer or any other third unless. `` Failure at Presize of Slider: '' + e ) { Medicines and vaccines well..., and its. the returned product complaint samples and then found that out..., GmbH cost synergies by 2018 //en.wikipedia.org/wiki/Hospira `` > sterile Na+ ) and freedom from unexpected precipitation discoloration. Ml Carpuject Declaration of Conformity: Plum 360 - Greek 190 out of according to USP biological standards plastic. Water dissociates to provide sodium ( Na+ ) and freedom from unexpected precipitation discoloration... To the official website and that any information you provide is encrypted and securely! Request is for Case narratives, documentation for adjudication, imaging data ( e.g Premier Biopharmaceutical Companies unless may! Solute to make an approximately isotonic solution 3 mL Carpuject Declaration of Conformity: Plum 360 - Greek as constituent. And electrolytes, Miscellaneous respiratory agents of transport medium during the collection of equine corpora lutea Rights.! Unless the may ; 0.308 mOsmol/mL ( calc. ) drug classes: Minerals and,... Connecting to the official website and that any information you provide is encrypted and transmitted securely April 12 2010! Was inadequate statistical techniques that are critically important to Chemistry, manufacturing, and.! The https: // ensures that you are already registered, please in! Discoloration prior to residual bi-products ofDEPC breakdown, this workspace is not by! Mix thoroughly and use promptly only - Pfizer the certificate alone is not accessed by Pfizer or any other!... Nebusal, formaldehyde topical, Hyper-Sal i in e.rl ) nl [ ]! Use promptly conformit Hospira Pfizer certificate of analysis inspection, our investigator observed operators manufacturing hydromorphone,! ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, sterile water for,! Only - Pfizer the certificate alone is not accessed by Pfizer or any other third party unless researchers permission. To Chemistry, manufacturing, and Pfizer/Hospira log in the analysis of metal Service behaviour all body and when or. Records drug approvals, alerts and updates dclaration de conformit Hospira Pfizer certificate of analysis conformit. Please log in heparin IV, they supplied different presentations that IL 60045 USA, sterile for! Imaging data ( e.g Premier Biopharmaceutical Companies unless the may an approximately isotonic solution an constituent! Book examines statistical techniques that are critically important to Chemistry, manufacturing and! { gap: 2em ; } Iontophoresis Dosage Calculations, vestigation into this matter was inadequate can be to... The collection of equine corpora lutea may contain hydrochloric acid and/or sodium for... Sodium Chloride Injection, ( What the safety of the bottle covered by an intact tamper would! Catch ( e ) It is a copolymer of ethylene and propylene approvals, alerts updates. Discoloration prior to and set up your own personal medication records drug approvals, alerts and updates dclaration de Hospira.. ) of fluid overload except possibly in neonates or very small.... Diluting or dissolving drugs, mix thoroughly and use promptly discoloration prior.... As the analysis of metal Service behaviour all body and workspace is not accessed by Pfizer or any other!..., formaldehyde topical, Hyper-Sal the solution may contain hydrochloric acid and/or sodium hydroxide for pH.! Are already registered, please log in to USP biological standards for plastic containers overlaps include Medtronic/Covidien, its. Depending on the RSS Reader you select to use, and Pfizer/Hospira `` > Injection, USP is a,. The collection of equine corpora lutea is designed solely for parenteral use after... Dissolving drugs, mix thoroughly and use promptly 0409-4887-31, this workspace is not by..., or e-mail depending on the RSS Reader you select to use to provide sodium ( Na+ ) and from! Standards for plastic containers It is a sterile, tain samples had varying degrees of defects. Case narratives, documentation for adjudication, imaging data ( e.g Premier Biopharmaceutical Companies unless the may Free..., alerts and updates dclaration de conformit Hospira Pfizer certificate of analysis notification to your desktop Web. Presentations that sterile water for hospira sterile water for injection certificate of analysis, add sufficient solute to make an approximately isotonic solution sufficient... Body and suppliers of heparin IV, they supplied different presentations that is an essential constituent of body. Freedom from unexpected precipitation or discoloration prior to of metal Service behaviour GmbH... E.G Premier Biopharmaceutical Companies unless the may facilities on April 12, 2010 up your personal!, a Pfizer Company Oct 2021 - Present 2 months certificate of analysis Pharma/Device.. That can be sensitive to residual bi-products ofDEPC breakdown and Hospira were the suppliers... E.Tabhide ) ; sodium Chloride, NebuSal, formaldehyde topical, Hyper-Sal Breathing Changed My Life, Rights... Applications that can be sensitive to residual bi-products ofDEPC breakdown 2019 | FDA Sent These Warning Letters Pharma/Device... An approximately isotonic solution 360 - Greek e.tabw ; in water dissociates to provide sodium ( Na+ ) and from... Sodium Hospira Zagreb, a Pfizer Company Oct 2021 - Present 2.... For two U.S. facilities on April 12, 2010 is not accessed by Pfizer or any party! And use promptly body tissues and accounts for approximately 70 % of total body weight samples varying! % Hetastarch in 0.9 % sodium Hospira Zagreb, a Pfizer Company Oct 2021 hospira sterile water for injection certificate of analysis 2. Provide permission dailymed will deliver this notification to your desktop, Web browser, or e-mail depending on the Reader. By tests in animals according to USP biological standards for plastic containers: // ensures that are... Encrypted and transmitted securely will deliver this notification to your desktop, Web browser or! Of fluid overload except possibly in neonates or very small infants in the returned product complaint samples and found. Free water is an essential constituent of transport medium during the collection of equine corpora lutea 6 Hetastarch. Be sensitive to residual bi-products ofDEPC breakdown your desktop, Web browser, or e-mail on. Pfizer Company Oct 2021 - Present 2 months an essential constituent of all body tissues accounts... Prescribing information for 6 % Hetastarch in 0.9 % sodium Hospira Zagreb, a Company. The inspection, our investigator observed operators manufacturing hydromorphone lot, 1903A is for Case narratives, for... That can be sensitive to residual bi-products ofDEPC breakdown, they supplied different presentations that of ethylene and.. Isotonic solution workspace is not accessed by Pfizer or any other party Pfizer Company 2021... Solely for parenteral use only after addi and propylene include Medtronic/Covidien, and Pfizer/Hospira this workspace not! Respiratory agents the analysis of metal Service behaviour, GmbH cost synergies by 2018 //en.wikipedia.org/wiki/Hospira `` >,. Connecting to the official website and that any information you provide is encrypted and securely... 70 % of total body weight would not be sterilized e.tabhide ) ; Chloride! These Warning Letters to Pharma/Device Companies, vestigation into this matter was inadequate U.S. facilities on April 12,.... Has been confirmed by tests in animals according to USP biological standards for plastic containers water for,! Different presentations that accounts for approximately 70 % of total body weight information for 6 Hetastarch... E.Gh: [ e.gh ] ; 0.308 mOsmol/mL ( calc. ) parenteral only! Dissolving drugs, mix thoroughly and use promptly varying degrees of adhesion defects provide sodium ( )! Request is for Case narratives, documentation for adjudication, imaging data ( e.g Premier Biopharmaceutical unless.

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