Park Compounding is voluntarily recalling one lot of Testosterone Cypionate (Sesame Oil) 200mg/mL for Injection.
A recent inspection by FDA investigators showed that methods used by Front Range Laboratories to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results.
If microbial contamination is found in products intended to be sterile, patients are at risk of serious infections which may be life-threatening.
The affected products have Lot # 05072013@1 with expiration date 11/3/2013. The injections were supplied in 10mL amber vials and were distributed during May and June 2013 in California and Indiana.
Customers that have the affected product should discontinue use and contact Park Compounding (949) 551-7195 to arrange for return of unused product.
For more information call (949) 551-7195 or visit the FDA safety alert website.