Drug product
Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
D-1192-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29 vials
- Official record key
drug-enforcement:D-1192-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: 12082102A2, Exp 3/8/2022; 02212201A1, Exp 5/22/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility