Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance

AUDIENCE: Health Professional, Patient

ISSUE: US Compounding, Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by USC and that remain within expiry 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.

BACKGROUND: The recall does not pertain to any non-sterile compounded medications prepared by USC.

RECOMMENDATION: USC is asking all patients and providers that received sterile compounded products from USC between March 14, 2015 and September 9, 2015, and that remain within expiry, to take the following actions:

Discontinue use of the products;
Quarantine any unused product until further instructions are received on how to return the product; and
Contact USC at 800-718-3588 x254 or 501-327-1222 x254 from the hours of 8:30AM-5:00PM central time Monday-Friday, or e-mail at questions@uscompounding.com to discuss the return of any unused sterile compounded products.

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 USC to a patient(s) for use outside of the provider's office should contact the patient(s) to whom product was dispensed and advise the patient(s) 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:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatxch safety alert, including links to the press release and recalled product list, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm464086.htm