Drug product
Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK
D-0002-2017
Product summary
- Event
- Event 75212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 419 mL total
- Official record key
drug-enforcement:D-0002-2017
Official wording
Reason: Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Code information: 071222016@24 BUD 01/08/2017, 05112016@8 BUD 11/07/2016
Distribution pattern: Oklahoma
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility