Drug product
Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
D-1216-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 191 vials
- Official record key
drug-enforcement:D-1216-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: a) 10282106A1, Exp 4/26/2022; 11022118A1, Exp 4/30/2022; 12292115A1, Exp 6/27/2022; b)12082113A2, Exp 6/2/2022; 12292115A1, Exp 6/27/2022; 03072230A1, Exp 9/3/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility