September 10, 2013 — Park Compounding has recalled one lot of testosterone steroid injections because they may not be sterile. The testosterone injections were sold in May and June 2013 in California and Indiana. They were sold directly to consumers (pick up and by mail) and to physician offices. No injuries have been reported.
The recall was issued after investigators from the U.S. Food and Drug Administration (FDA) found problems at Front Range Laboratories, which did sterility testing for Park Compounding and other compounding pharmacies. The FDA is concerned that results obtained from the laboratory are not reliable.
This is the second recall for Park Compounding in the last couple weeks. Another recall was issued on August 23 for methylcobalamin, a form of vitamin B-12, and Multitrace-5 concentrate, a trace element supplement. The products were sold directly to consumers and doctors from June until July 2013 in California, Florida, New Mexico, and Indiana.
Recalled medicines from Park Compounding include:
- Testoserone Cypionate — (Sesame Oil) 200mg/ml Lot #05072013@1 Exp: 11/3/2013 for injection in 10ml amber vials
- Methylcobalamin — 5mg/ml 30ml Amber Vials Lot #06132013@1 Exp: 12/10/2013
- Multitrace-5 Concentrate — 10ml Amber Vials Lot #05212013@20 Exp: 11/17/2013
Problems with sterility testing at Front Range Laboratories also led to a recall from Avella Specialty Pharmacy. Microbial contamination of injection medicines can lead to life-threatening blood infections, fungal meningitis, and other serious injuries.