Drug product
Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
D-1202-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 45
- Official record key
drug-enforcement:D-1202-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: 10132102A2, Exp 3/22/2022; 01062221B, Exp 4/30/2022; 11302103A1, Exp 4/30/2022; 03032227A1, Exp 8/29/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility