Home > Blog > Park Compounding Recalls Testosterone

Testosterone Cypionate is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.  Here is an example of an individual apparently injecting himself with Testosterone Cypionate.

Tuesday, the FDA announced that Park Compounding has elected to voluntarily recall one lot of sterile medication.  The injectable medication, Testosterone Cypionate (Sesame Oil) 200mg/ml Lot #05072013@1 Exp: 11/3/2013 in 10ml amber vials, to the consumer level. The recall followed an FDA inspection in which FDA investigators found that Front Range Laboratories’ methods to assess sterility may have yielded inaccurate lab test results, which were then transmitted to pharmacies, which dispensed the medication.  Simply stated, the FDA recall reflects its concern that the results obtained from the laboratory are not reliable.

The prescription preparations were sold during May and June of 2013, in California and Indiana. The products would have been sold directly to customers (pick up and by mail) and to physician offices by prescription (pick up and by mail).

Significantly, there have not been any reports of adverse events associated with the use of these products and there has been no confirmation that these products are, in fact, not sterile. Nevertheless, the risk that led to the FDA action is that when there is microbial contamination in products intended to be sterile, patients are at risk of serious, potentially life-threatening infection.

According to the FDA, Park Compounding is notifying its customers by phone and mail and is arranging for the return of all recalled product lots. They advise those that are in possession of the recalled product should stop using it and contact Park Compounding to arrange for it to be returned.