MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramTri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility AssuranceAUDIENCE: Pharmacy ISSUE: Tri-Coast Pharmacy Inc. is voluntarily recalling all sterile products prepared between May 17, 2016 and November 17, 2016 and that remain within expiry due to FDA concerns over the lack of sterility assurance of the drugs named in this recall. Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening. No portion of any lot of these medications has been found to be non-sterile, but the FDA is concerned that the conditions under which they were produced introduce a lack of sterility assurance for these products. See the press release for a list of affected products. BACKGROUND: The recalled drug products were used for a variety of indications. All recalled products have a Tri-Coast Pharmacy Inc. label that includes the name Tri-Coast Pharmacy Inc., the logo, the drug name, lot number and the expiration date. RECOMMENDATION: All patients and providers that received any sterile compounded products from Tri-Coast Pharmacy Inc. prepared between May 17, 2016 and November 17, 2016 and that remain with expiry, should take the following actions:
Patients should contact their physician or healthcare provider if they have experienced any problems that may be associated with using these products. Providers who have dispensed any sterile products prepared between May 17, 2016 and November 17, 2016 to a patient should contact the patient(s) to whom the product was dispensed and make the patient(s) aware of this recall. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch safety alert, including a link to the press release, at: You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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