Drug product
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
D-0450-2022
Product summary
- Event
- Event 89323
- Status
- Terminated
- Classification
- Class II
- Quantity
- 792 bottles
- Official record key
drug-enforcement:D-0450-2022
Official wording
Reason: Superpotent and Failed Tablet/Capsule Specifications
Code information: Batch # PF4520028B & PF4520028A, Exp. Date 11/2022
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
Superpotent