University Compounding Pharmacy Recalls Some Products Due to Lack of Sterility Assurance

Topics: Compounding and Fda

Food and Drug Administration (FDA) and University Compounding Pharmacy of San Diego, CA, have issued a voluntary recall of several products including Testosterone Cypionate (Sesame Oil) 200 mg/mL Inj., Testosterone Cypionate/Testosterone Proprionate 180-20 mg/mL Inj., and PGE-1 NS 20 mcg/mL Inj. to the consumer level. The company initiated the recall after a recent FDA inspection raised concerns about methods used by an independent third-party laboratory to assess sterility, which may have resulted in pharmacies receiving inaccurate laboratory testing results. To date there have been no adverse events associated with the use of these products, and there has been no confirmation of lack of sterility. A list of affected products including lot numbers, expiration dates, and dates of distribution are included in a news release posted on the FDA Web site. Customers affected by the recall may contact the company at 619/683-2005 to ask questions, or to arrange for the return of any unused products. Adverse reactions may be reported to FDA’s MedWatch Adverse Event Reporting Program.