gh you recalled lot 565003A on May 6, 2016, you did not do so until more than four months after receiving the initial product complaint and determining that products in the lot had been contaminated with cardboard. for (var i in nl) if (sl>nl[i] && nl[i]>0) { sl = nl[i]; ix=i;} This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Water balance is maintained by various regulatory mechanisms. Water balance is maintained by various regulatory mechanisms. PubMed, Contacting the Drug. Hospira, Inc., FEI 1021343 and FEI 1048698: Warning Letter 10-ATL-12. Get pharmaceutical product and services; of 6 /6. The investigator observed the introduction of a bottle of sterile water with a shrink- wrapped plastic tamper-resistant seal into the, tor material transfer chamber. body{--wp--preset--color--black: #000000;--wp--preset--color--cyan-bluish-gray: #abb8c3;--wp--preset--color--white: #ffffff;--wp--preset--color--pale-pink: #f78da7;--wp--preset--color--vivid-red: #cf2e2e;--wp--preset--color--luminous-vivid-orange: #ff6900;--wp--preset--color--luminous-vivid-amber: #fcb900;--wp--preset--color--light-green-cyan: #7bdcb5;--wp--preset--color--vivid-green-cyan: #00d084;--wp--preset--color--pale-cyan-blue: #8ed1fc;--wp--preset--color--vivid-cyan-blue: #0693e3;--wp--preset--color--vivid-purple: #9b51e0;--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple: linear-gradient(135deg,rgba(6,147,227,1) 0%,rgb(155,81,224) 100%);--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan: linear-gradient(135deg,rgb(122,220,180) 0%,rgb(0,208,130) 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Consult with pharmacist, if available. 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 e.gh : [e.gh]; Sodium chloride systemic 1 gram (CMC 176). 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! 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. Sodium Chloride Injection Hospira Description This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be .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} For I.V. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. e.gh = Array.isArray(e.gh) ? Declaration of Conformity: Plum 360 - Greek. If a water bottle is inserted into the chamber with an intact seal, only the exposed surfaces of the bottle would be rendered sterile. All rights reserved. Starbucks Reserve Nyc, 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. display: inline !important; sence of multiple foreign particulates in your products is unacceptable. Factors informing this view in relation to small molecule drugs included: . 70% Denatured Ethanol and 30% USP Water for Injection, 11 oz Aerosol Mist Bottles. [See USP Controlled Room Temperature. The LpH, low in particles and extractable residue making it ideal for critical cleaning. Extrinsic contaminants, such as cardboard, pose a significant risk to patients and indicate that your process for manufacturing sterile injectable products is out of control. ing the inspection, our investigator observed operators manufacturing hydromorphone lot, 1903A. There is no scientific justification for the number of reserve samples you select for examination. This transcript may contain forward-looking statements about, among other things, our anticipated operating and financial performance, 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, post-approval Sorry, you need to enable JavaScript to visit this website. if(e.layout==="fullscreen" || e.l==="fullscreen") 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. Copyright 2021 ryan-singlehurst.com. Are to be used for products manufactured by TSK Laboratory and Henke-Sass Wolf, GmbH terms and conditions underlined Formulated polyolefin have unanimously approved the deal an essential constituent of all our stakeholders day. Agreements for voriconazole Injection and melphalan hydrochloride Injection to Alvogen, 250, 500 and mL., USP is chemically designated NaCl, a white crystalline compound freely soluble water 10Th, 2019 | FDA Sent these Warning Letters to Pharma/Device companies LinkedIn! Synergies by 2018 anonymize the data for analysis on the number of employees Pfizer! Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. You released lot, nufacturing process. However, you did not determine whether the same problem may have. cited in this letter are not intended as an all-inclusive list. these violations are corrected, we may withhold approval of pending drug applications listing your facility. It is a copolymer of ethylene and propylene. Water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. Hospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. 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. 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.
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hospira sterile water for injection certificate of analysis
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