University Compounding Pharmacy Injection Products: Recall - Lack of Sterility Assurance

[Posted 09/08/2013]

AUDIENCE: Consumer, Pharmacy, Patient, Health Professional

ISSUE:  University Compounding Pharmacy is voluntarily recalling products, including Testosterone Cypionate (Sesame Oil), Testosterone Cypionate/Testosterone Proprionate, and PGE-1 NS, for injection, to the consumer level (refer to Recall Notice for a detailed product list with affected lot numbers and expiry dates).  In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

BACKGROUND: The prescription preparations were distributed nationwide from May 9th, 2013 to September 7th, 2013.The preparations would have been sold, directly to customers by pick up and by mail. 

RECOMMENDATION:  Customers that have product which is being recalled should stop using it and contact University Compounding Pharmacy to arrange for return of unused product. Customers with questions regarding this recall can contact University Compounding Pharmacy at 1875 Third Ave, San Diego CA 92101 619-683-2005.

Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these preparations.

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.htm
• 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

[09/08/2013 - Recall Notice - FDA]