Drug product
Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA
D-1027-2013
Product summary
- Event
- Event 66083
- Status
- Terminated
- Classification
- Class II
- Quantity
- 117 vials
- Official record key
drug-enforcement:D-1027-2013
Official wording
Reason: Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance.
Code information: Lot #05072013@1, Exp 11/3/2013
Distribution pattern: CA, IN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility