Drug product
S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
D-1316-2015
Product summary
- Event
- Event 71618
- Status
- Terminated
- Classification
- Class II
- Quantity
- 750 mL
- Official record key
drug-enforcement:D-1316-2015
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 #: 05012015@4, BUD 10/28/2015
Distribution pattern: Oklahoma
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility