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US Compounding Recalls Sterile Products Due to Sterility Issues
US Compounding, Inc., is voluntarily recalling all lots of sterile products that it has aseptically compounded and packaged due to FDA concern over a lack of sterility assurance. The sterile products were distributed nationwide to patients, providers, hospitals, or clinics between March 14, 2015, and September 9, 2015. If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.
The recall does not pertain to any nonsterile compounded medications prepared by USC.
USC is asking all patients and providers who received sterile compounded products from it during the time in question to discontinue use of any unexpired products and quarantine them until instructions are received on how to return them. Customers can contact USC by telephone at 800-718-3588, extension 254, or 501-327-1222, extension 254, from 8:30 a.m. to 5 p.m. Central time, Monday through Friday, or by email at email@example.com to discuss the return of any unused sterile compounded products.
Providers who have dispensed any sterile product distributed by USC to patients for use outside of the provider's office should contact those patients and advise them of this recall.
Health care 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.
Source: FDA; September 24, 2015.