Drug product
Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding
D-1240-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 75 vials
- Official record key
drug-enforcement:D-1240-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: a) 01252201A2, Exp 3/26/2022; b) 01252201A2, Exp 3/26/2022; 02032213A2, Exp 4/4/2022; 03042209A1, Exp 5/3/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility