Drug product
Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room Temperature, Tailor Made Compounding
D-1214-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 232 vials
- Official record key
drug-enforcement:D-1214-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: a) 12092105A2, exp 3/9/2022; 01042219A2, Exp 4/4/2022; 01202210A2, exp 4/20/2022; 01282207A1, exp 4/28/2022; 03032217A1, Exp 6/1/2022; 12092105A2; b) 01282207A1, Exp 4/28/2022; 03032241A1, Exp 6/1/2022
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility