Drug product
Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
D-1208-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 63 vials
- Official record key
drug-enforcement:D-1208-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: 12222104A2, Exp 3/22/2022; 01032224A2, Exp 4/3/2022; 01282217A2, Exp 4/28/2022; 02192211A1; Exp 5/20/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility