Drug product
Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding
D-1217-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 vials
- Official record key
drug-enforcement:D-1217-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: 03012234A1, Exp 8/28/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility