Drug product
Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made Compounding
D-1209-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26 vials
- Official record key
drug-enforcement:D-1209-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: 01032236A2, Exp 4/3/2022; 03072232A1, Exp 6/5/2022
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility