September 10, 2013 — Park Compounding has announced a voluntary recall of one lot of a testosterone steroid injection because it may not be sterile. The testosterone injections were sold directly to consumers and doctors (pick up and by mail) from May until June 2013 in California and Indiana.
This is the second major recall for Park Compounding in the last few weeks over concerns about sterility issues at Front Range Laboratories, and independent sterility testing laboratory. Problems with the lab also led Avella Specialty Pharmacy to recall two medicines last week. No illnesses or injuries have been reported.
Inspectors from the U.S. Food and Drug Administration (FDA) warn that pharmacies who use Front Range Laboratories may receive inaccurate sterility testing results. Patients who receive a non-sterile injection medication can develop life-threatening bloodstream infections, sepsis, fungal meningitis, and other complications.
On August 23, Park Compounding recalled a vitamin B-12 supplement called methylcobalamin and a trace element supplement called Multitrace-5 concentrate. The products were sold in California, Florida, New Mexico, and Indiana from June until July 2013.
Park Compounding medicine recalls 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
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