Drug product
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
D-1025-2013
Product summary
- Event
- Event 66083
- Status
- Terminated
- Classification
- Class II
- Quantity
- 297 vials
- Official record key
drug-enforcement:D-1025-2013
Official wording
Reason: Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.
Code information: Lot #06132013@1, Exp 12/10/2013
Distribution pattern: CA, IN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility