Drug product
Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
D-1210-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 25 vials
- Official record key
drug-enforcement:D-1210-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: 01212203A2, Exp 4/21/2022; 02232213A1, Exp 5/24/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility