US Compounding, Inc. (USC) is voluntarily recalling all lots of sterile products aseptically compounded and packaged by USC and that are still within its expiry. This recall is due to the Food and Drug Administration 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. USC is asking all patients and providers who received these products to:
• 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 8:30 AM-5 PM Central Standard Time
Monday-Friday, or e-mail at firstname.lastname@example.org to discuss the return of any unused sterile compounded products.
Customers should contact their physician or health care 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.
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:
• 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