Drug product
S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1962-40
D-1289-2015
Product summary
- Event
- Event 71618
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64 mL
- Official record key
drug-enforcement:D-1289-2015
Official wording
Reason: Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Code information: Lot #s: 03132015@28, BUD 9/9/2015; 04082015@46, BUD 10/5/2015; 04222015@5, BUD 10/19/2015
Distribution pattern: Oklahoma
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility