MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramSterile Compounded Products by Isomeric Pharmacy Solutions: Recall - Lack of Sterility AssuranceAUDIENCE: Patient, Pharmacy ISSUE: Isomeric Pharmacy Solutions (“Isomeric”) is voluntarily recalling all lots of sterile products compounded and packaged by Isomeric and that remain within expiry to the hospital/user level because of FDA concerns of a lack of sterility assurance. These concerns were brought to Isomeric’s attention during a recent FDA inspection. The sterile products were distributed to patients, providers, hospitals, or clinics nationwide between October 4, 2016 and February 7, 2017. See the press release for a link to list of all drugs affected by this recall. BACKGROUND: To date, Isomeric has not received any reports of adverse events related to this recall. This recall does not pertain to any non-sterile compounded medications prepared by Isomeric. RECOMMENDATION: Isomeric is notifying its customers of the recall by mail and telephone or email and is arranging for a return of all recalled products that remain unused. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Providers who have dispensed any sterile product distributed by Isomeric to a patient(s) for use out of the provider’s office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall. Isomeric is asking all patients and providers that received sterile compounded products from Isomeric between October 4, 2016 and February 7, 2017, and that remain within expiry, to take the following actions:
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).
|
