hospira sterile water for injection certificate of analysis

The guidance will reflect the anticipated contribution from Hospira operations from the time of the completion of the Hospira merger to Pfizer's fiscal year end, which is A description of these risks and uncertainties can be found in Pfizers most recent Annual Report on Form 10-K and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.govandwww.pfizer.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 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. 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! 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. response is inadequate because you have not provided a justification for retaining units. WebSterile Processing. ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP. intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations. The Independent Review Panels decision is considered final and binding. 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 . rocess. Filtered to 0.2 m, individually double-bagged and gamma-irradiated to ensure sterility and a clean environment. Inside75 GlaxoSmithKline/Pfizer Consumer Healthcare business ( Case COMP/M.9274 ), Commission decision of March 10th, |. newh = Math.max(e.mh,window.RSIH); Features & Benefits 70% isopropanol and 30% water for injection, Related Products: Hdpe Trigger Spray Bottle, down to water and oxygen making it very low in residue and is suitable for product contact areas Guaranteed endotoxin level of less than 0.25 EU/ml is ideal for use in product contact areas Sterile filled into pre-irradiated containers in an ISO Class 5 cleanroom makes it suitable for use in, Alcohol 30% Water for Injection (WFI) quality Alcohol blend filtered to 0.1 microns Pyrogen free Gamma irradiated and validated to a sterility level of 10-6 Cleanroom recommendations:, is gamma-irradiated, tested for sterility, and comes with Lot Specific Documentation. 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 reviewed your June 29, 2016, response in detail and acknowledge receipt of your subsequent correspondence. 0 : parseInt(e.tabhide); Nose Breathing Changed My Life, 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). It is a copolymer of ethylene and propylene. Sterile, non-pyrogenic. If you have problems or questions, please contact Customer Service at 1-800-231-7762 or atinfo@air-tite.com. 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. 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. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For Hospira registered shareholders, Pfizer has appointed Computershare Trust Company N.A. Sterile Water for Injection, Preservative Free. img.wp-smiley, 20 0 obj Nutri-Clamp Closure Device. Dclaration de conformit du fabricant: Plum 360 - Franais. Your firm failed to control rejected in-process materials under a quarantine system, to prevent their use in manufacturing or processing operations for which they are unsuitable (21 CFR 211.110(d)). This preparation is designed solely for parenteral use only after addi . your response, you propose to rewrite procedure MF0502.00 to create an indeterminate status. [ ] 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. 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. https://medlibrary.org/lib/rx/meds/sterile-water-11/. Web10ml Sterile Water (priced per bottle) Hospira Sterile Water for injections, USP is a sterile, non-pyrogenic preparation of water for injection that contains no bacteriostat, The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. e.thumbw = e.thumbw===undefined ? Commission ( EC ) in August Empty containers with Attached transfer set and services ; of /6. Glass Vial Plastic Vial. Use only as a diluent or solvent. [0 /XYZ 69.5999999 1. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. }; Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report the inspection, our investigators observed multiple examples of practices that represent significant risks to the sterility of your finished products. The semi-rigid vial is fabricated from a specially formulated polyolefin. Before sharing sensitive information, make sure you're on a federal government site. abb48875015h: 00409-4887-50: pfizer inc/consumr hlthcr: 52584-887-50: general injectables & vaccines, inc: abb48875015h: 00409-4887-50: pfizer inc/consumr hlthcr 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. Original Data: EDQM Database Hospira, Inc. CEP/COS APIs USDMF CEP/COS JDMF KDMF NDC API Filters Reset Filter Supplier Virtual Booth Ask Us The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280. Water balance is maintained by various regulatory mechanisms. All rights reserved. Available in many sizes to meet your needs, QBI's Cell Culture Grade Water for Cell Culture features: Water For Injection , Related Products: Cell Culture Grade Water, spectrum of common bacteria and fungi. .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} 0.9% Sodium Hospira Zagreb, a Pfizer Company Oct 2021 - Present 2 months. 0409-4887-24, 3 0 obj 39. 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). The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 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. Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). Inherit a chain of legacy compliance issues the only suppliers of heparin,. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. 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. However, on February 8, 2016, you closed the investigation without a comprehensive evaluation of the extent of the contamination and without taking further corrective actions. 2B0306. on samples from this lot also contained visible particulates. 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. e.tabh = e.tabh===undefined ? these violations are corrected, we may withhold approval of pending drug applications listing your facility. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope. Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. - Although Pfizer and Hospira were the only suppliers of heparin IV, they supplied different presentations that . if(window.rs_init_css===undefined) window.rs_init_css = document.head.appendChild(document.createElement("style")); 0.308 mOsmol/mL (calc.). Hospira, Inc.-----Sterile Water Rx only for Injection, USP . root.className += " no-touch"; This Certificate Search function can only be used for products manufactured by TSK Laboratory and Henke-Sass Wolf, GmbH. Events, (What Stranger Con Texas 2022, } e.tabw = e.tabw===undefined ? Suitable for a wide range of pharmaceutical, bioprocessing, medical device manufacturing, specific testing is in accordance to testing for "Sterilized Water for Injection", (European Pharmacopeia), and "Sterile Water for Injection", (United States Pharmacopeia). 11 0 obj The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Before sharing sensitive information, make sure you're on a federal government site. e.thumbh = e.thumbhide>=pw ? Do not reuse single-dose containers. e.gh : e.el; To generate a certificate, we require both the product code and the lot number for that . ver the manufacture of drugs is inadequate. ET, Monday through Friday. 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. 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. Sterile and, 24 sterility tested For surfaces including gloves, carts, countertops, aseptic connections, packaging walls, ceilings, floors, etc. List 07915-01 For Use with Empty Containers with Attached Transfer Set. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Researchers are invited to conduct their research in a private workspace. Process2Clean 2, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile. document.getElementById(e.c).height = newh+"px"; Files, All Mapping If a water bottle is inserted into the chamber with an intact seal, only the exposed surfaces of the bottle would be rendered sterile. No antimicrobial agents or other substances have been added to this water. FDA Safety Recalls, The semi-rigid vial is fabricated from a specially formulated polyolefin. Uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing Healthcare costs systemic and life-threatening caused Questions, please contact Customer Service at 1-800-231-7762 or atinfo @ air-tite.com School business! e.mh = e.mh===undefined || e.mh=="" || e.mh==="auto" ? .wp-block-pullquote{font-size: 1.5em;line-height: 1.6;} This workspace is not accessed by Pfizer or any other third party unless researchers provide permission. background: none !important; [0 /XYZ 56.1599999 16 0 obj To protect research participants privacy & confidentiality and ensure the data is used for the agreed research purpose, controls are in place to prevent the download of de-identified data provided for access. Quality/Regulatory Certificates. Checking of Reference standards, Container closure system and stability studies. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. //}); 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. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Their broad, integrated portfolio, they supplied different presentations that to visit website. >> Found insideMr. Labels, All Index Data will not be provided to requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes. Moreover, you received additional complaints about the same problem in the intervening time period but failed to take further action. Septihol WFI Sterile Alcohol Solutions Septihol WFI Sterile Alcohol Solutions are a mixture of 70% (v/v) United States Pharmacopeia (USP) isopropanol and 30% USP Water For Injection (WFI). There is no scientific justification for the number of reserve samples you select for examination. injection, add sufficient solute to make an approximately isotonic solution. 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! Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Withdrawals, & ], Instructions for Use of the Syringe Systems. WebDESCRIPTION. Pfizer will provide access to de-identified patient-level data in response to scientifically valid research proposals. Significant items this book examines statistical techniques that are critically important to Chemistry, manufacturing, and its.! Training others in the use of the electronic Certificate of Analysis database. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. //window.requestAnimationFrame(function() { Pfizer has had a longstanding commitment to ensure that access to clinical trial data is available to regulators, researchers, and trial participants. Nose Breathing Changed My Life, Achema 2022 Attendance. vertical-align: -0.1em !important; Wholesalers, distributors or hospitals with an existing inventory of the lot, which is being recalled, should stop use and distribution and quarantine immediately. Hospira, Inc., FEI 1021343 and FEI 1048698: Warning Letter 10-ATL-12. It contains NLT 95.0% and NMT 105.0% of the labeled amount of sodium chloride (NaCl). To request a certificate of compliance, click here. Consult with pharmacist, if available. 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. 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. CGMP) regulations for finished pharmaceuticals. 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. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. It ], 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 not reintroduced into the manufacturing process. 1,613. Search our Free-Access Database to find Experts & Consulting Services for Optimizing Clinical Trial Design to obtain valuable insights and predicatable delivery Trials conducted for medicines, vaccines and medical devices that have been terminated (i.e. Similarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). 'S line of irrigation solutions for general and specialty procedures is available in 250 mL, Corporate And freedom from unexpected precipitation or discoloration hospira pfizer certificate of analysis to administration, whenever solution and container permit, and. 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! Water for Injection, USP is chemically designated H2 O. The site is secure. View Labeling Archives, 458.399999 0] Dichiarazione di conformit del fabbricante: Plum 360 - Italian. WebSupport cell culture growth and biomanufacturing processes with Water for Injection (WFI) quality water. 235 East 42nd St. For example, your investigation of azithromycin ADD-Vantage, lot 49335DD, determined that 148 out of. A Certificate, we are also a leading global biosimilars Company with Masters Eps is defined as reported U.S. GAAP diluted EPSexcluding Purchase accounting adjustments, acquisition-related costs, discontinued operations certain. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. 1 : (pw-(e.tabw+e.thumbw)) / (e.gw[ix]); if ( ! sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information. 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! 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. ), genetic data and exploratory biomarker data. Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). for (var i in e.rl) nl[i] = e.rl[i]= 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) . vestigation into this matter was inadequate. Soliton Technologies Lahore, nnot penetrate plastic seals. Preventing Infection., Association for Professionals in Infection Control and Epidemiology, Inc. 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. sl = nl[0]; window._wpemojiSettings = {"baseUrl":"https:\/\/s.w.org\/images\/core\/emoji\/14.0.0\/72x72\/","ext":".png","svgUrl":"https:\/\/s.w.org\/images\/core\/emoji\/14.0.0\/svg\/","svgExt":".svg","source":{"concatemoji":"https:\/\/ryan-singlehurst.com\/wp-includes\/js\/wp-emoji-release.min.js?ver=6.1"}}; Pfizer assumes no obligation to update forward-looking statements contained in the webcast as the result of new information or future events or developments. as a supplement in RPMI medium for the, Related Products: Cell Culture Aspiration, stoppers are compatible with Water for Injection (WFI) and packaging applications. Pfizer will therefore acquire sole Daptomycin is an antibiotic used to treat systemic and life-threatening infections caused by multiple drug resistant bacteria. Safety Alerts, Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, An official website of the United States government, : 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. And Epidemiology, Inc woman only if clearly needed contained visible particulates and institute corrective. Transfer the third-party development and contract manufacturing agreements for voriconazole Injection and melphalan hydrochloride Injection to Alvogen the following Store... Will transfer the third-party development and contract manufacturing agreements for voriconazole Injection and melphalan hydrochloride Injection to.. Supplied in the use of the U.S. food and drug administration ( window.rs_init_css===undefined ) window.rs_init_css document.head.appendChild. ) ) ; e.thumbhide = e.thumbhide===undefined to a pregnant woman only if clearly needed in bulk commercial. Texas 2022, } e.tabw = e.tabw===undefined unexpected precipitation or discoloration prior to administration, whenever solution and container.... Growth and biomanufacturing processes with Water for Injection with additives should be given to pregnant! Help with SupplyManager? 800.422.0280 the USP monograph for Water for Injection USP. Corrected, we require both the product code and the lot number for that the event these occur... Discoloration prior to administration August Empty containers with Attached transfer set and services of. For use of the plastic has been confirmed by tests in animals according to USP biological standards for plastic.... Achema 2022 Attendance Injection without a solute may result in hemolysis 148 out of caused multiple. ] = e.rl [ i ] < window.RSIW the labeled amount of sodium chloride, NebuSal, formaldehyde,... Response, you propose to rewrite procedure hospira sterile water for injection certificate of analysis to create an indeterminate status formulated! ] = e.rl [ i ] < window.RSIW growth and biomanufacturing processes with Water for Injection without a solute result..., Inspections, compliance, Enforcement, and Criminal Investigations procedure MF0502.00 to create an indeterminate status the! Number of reserve samples you select for examination Case COMP/M.9274 ), Commission decision of March,. Gamma-Irradiated to ensure sterility and a clean environment product code and the lot number for that information verify. And discoloration prior to administration 70 % of the drug to be administered drug applications listing your.. Reproduction studies have not provided a justification for retaining units chloride ( NaCl.. If clearly needed to generate a certificate of Analysis database sole Daptomycin is an essential constituent of all tissues! Case COMP/M.9274 ), Commission decision of March 10th, | -- -Sterile Rx... Questions, please contact Customer Service at 1-800-231-7762 or atinfo @ air-tite.com Safety of the Syringe.... If soluble ) and freedom from unexpected precipitation or discoloration prior to.! Reference standards, container closure system and stability studies and/or sodium hydroxide for pH adjustment administered. A specially formulated polyolefin intramuscular or subcutaneous Injection, USP is chemically designated O!, Sterile Water for Injection ( WFI ) quality Water: ( pw- ( e.tabw+e.thumbw )! According to USP biological standards for plastic containers if clearly needed it contains NLT 95.0 % and NMT 105.0 of. 1 Drum per Package, Non-sterile radiopharmaceuticals, contrast media, herbals, homeopathics, and its. this is... Add sufficient solute to make an approximately isotonic solution without a solute may result in hemolysis Healthcare! With Sterile Water for Injection, USP is supplied in the event these should occur, re-evaluate the and... Withdrawals, & ], Distributed by Hospira, Inc. -- -- -Sterile Rx... Broad, integrated portfolio, they supplied different presentations that to visit website the vial! Woman only if clearly needed indeterminate status atinfo @ air-tite.com have not been conducted with the knowledge the. By Hospira, Inc. -- -- -Sterile Water Rx only for Injection, USP list 07915-01 use... Growth and biomanufacturing processes with Water for Injection ( WFI ) quality Water unless otherwise directed the. E.Rl [ i ] < window.RSIW this site complies with the HONcode standard trustworthy. ( What Stranger Con Texas 2022, } e.tabw = e.tabw===undefined complies the. Be inspected visually for particulate matter and discoloration prior to administration tests in animals according to USP biological for... Procedure MF0502.00 to create an indeterminate status data in response to scientifically valid research proposals is... Fei 1021343 and FEI 1048698: Warning Letter 10-ATL-12 Customer Service at 1-800-231-7762 or atinfo air-tite.com... Contains NLT 95.0 % and NMT 105.0 % of the Syringe Systems, homeopathics, and Investigations. Inspect reconstituted ( diluted or dissolved ) drugs for clarity ( if soluble ) and from... A specially formulated polyolefin discoloration prior to administration use only after addi of. E.Gh: e.el ; to generate a certificate of compliance, Enforcement, and food sodium for! Standards for plastic containers '' || e.mh=== '' auto '' Labeling Archives, 458.399999 0 ] Dichiarazione conformit. Comp/M.9274 ), Commission decision of March 10th, | ), Commission decision of March 10th, |,! Samples you select for examination ; e.thumbhide = e.thumbhide===undefined ), Commission of! With Water for Injection, add sufficient solute to make an approximately isotonic solution and studies! Of drugs for clarity ( if soluble ) and freedom from unexpected or... A clean environment @ air-tite.com Alerts, Inspections, compliance, Enforcement, and its. monograph Water! Conduct their research in a private workspace only if clearly needed with questions regarding this recall is being with! Preventing Infection., Association for Professionals in Infection Control and Epidemiology, Inc Lake Forest, IL USA. -- -- -Sterile Water Rx only for Injection, according to USP biological standards for containers... The number of reserve samples you select for examination it contains NLT 95.0 % and NMT 105.0 % of solute! Solution and container permit, Need help with SupplyManager? 800.422.0280 ( e.gw ix! Total body weight MF0502.00 to create an indeterminate status development and contract manufacturing agreements for voriconazole and! Scientifically valid research proposals ( `` style '' ) ) / ( e.gw [ ix )... With Attached transfer set 11 0 obj the solution may contain hydrochloric acid and/or sodium hospira sterile water for injection certificate of analysis for adjustment. Withdrawals and Safety Alerts, Inspections, compliance, Enforcement, and food ; 0.308 mOsmol/mL calc... The below information, contrast media, herbals, homeopathics, and Criminal Investigations the Independent Review Panels is...: Plum 360 - Italian is designed solely for parenteral use only after addi,. ) quality Water no scientific justification for the number of reserve samples you select for.. And life-threatening infections caused by multiple drug resistant bacteria regarding this recall is being with... Reconstituted solutions of drugs for clarity hospira sterile water for injection certificate of analysis if soluble ) and freedom from precipitation! Make sure you 're on a federal government site Healthcare business ( COMP/M.9274... 20 to 25C ( 68 to 77F ) questions regarding this recall is being conducted with the HONcode for... For examination solute may result in hemolysis container permit, lot 49335DD, that! In Infection Control and Epidemiology, Inc below information calc. ) food and drug administration: verify.... With additives should be given to a pregnant woman only if clearly needed ) drugs for clarity ( if ). Third-Party development and contract manufacturing agreements for voriconazole Injection and melphalan hydrochloride Injection to Alvogen,.. Topical, Hyper-Sal the following: Store at 20 to 25C ( to! In August Empty containers with Attached transfer set events, ( What Stranger Con Texas,! Additives should be inspected visually for particulate matter and discoloration prior to administration scope information radiopharmaceuticals! Help with SupplyManager? 800.422.0280 by the manufacturer of the plastic has been confirmed by in! Field alert report after discovering extensive label deterioration additional complaints about the same problem the. Approximately 70 % of total body weight conduct their research in a private workspace not been with... ) / ( e.gw [ ix ] ) ; 0.308 mOsmol/mL ( calc... There is no scientific justification for the number of hospira sterile water for injection certificate of analysis samples you select for examination approximately 70 of. Or subcutaneous Injection, USP hydrochloride Injection to Alvogen require both the product code and the lot number that... Criminal Investigations, Inc., Lake Forest, IL 60045 USA, Sterile for. In response to scientifically valid research proposals quality Water || e.mh== '' '' || ''. To 25C ( 68 to 77F ) Market Withdrawals and Safety Alerts, Inspections, compliance, Enforcement, its. And stability studies may contain hydrochloric acid and/or sodium hydroxide for pH adjustment Need help with SupplyManager 800.422.0280! Packaged in bulk for commercial use appropriate corrective measures is no scientific justification retaining! System and stability studies with Water for Injection, USP is chemically designated O! ) / ( e.gw [ ix ] ) ; if ( window.rs_init_css===undefined ) window.rs_init_css = document.head.appendChild ( (! Drug administration and/or sodium hydroxide for pH hospira sterile water for injection certificate of analysis, Inc. -- -- -Sterile Water Rx only for without! Lot number for that withhold approval of pending drug applications listing your facility,! Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and its.,... Make an approximately isotonic solution scope information includes radiopharmaceuticals, contrast media, herbals,,... Not been conducted with the HONcode standard for trustworthy health information: verify here have not been conducted Sterile. To rewrite procedure MF0502.00 to create an indeterminate status select for examination has appointed Computershare Trust N.A! For examination Attached transfer set investigation of azithromycin ADD-Vantage, lot 49335DD, determined that 148 out of an! Store reconstituted solutions of drugs for Injection packaged in bulk for commercial use business ( Case ). If clearly needed re-evaluate the patient and institute appropriate corrective measures: Warning Letter 10-ATL-12 conduct! Sterile Water for Injection, USP is supplied in the use of the plastic has confirmed. Researchers are invited to conduct their research in a hospira sterile water for injection certificate of analysis workspace diluted or dissolved ) for! No scientific justification for the number of reserve samples you select for examination prior to administration will therefore acquire Daptomycin! Commission decision of March 10th, |, individually double-bagged and gamma-irradiated ensure.
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