Drug product
Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b) Multi-Dose 30mL vial, NDC 73198-0051-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
D-0936-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 12800 vials
- Official record key
drug-enforcement:D-0936-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: L24122, L24C22, L24B22 BUD: 6/22/2022, A24124-22 BUD: 7/24/2022, A24225-22 BUD: 7/25/2022, A24026-22 BUD: 7/26/2022, A24027-22 BUD: 7/27/2022, A24C31-22, A24B31-22 BUD: 7/31/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility