D-0450-2022 Class II Terminated
FDA drug recall D-0450-2022 was initiated by Aurobindo Pharma USA Inc. on December 29, 2021 and is designated Class II. Reason for recall: Superpotent and Failed Tablet/Capsule Specifications The recall status is terminated (terminated December 4, 2023). Affected quantity: 792 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 2, 2022
- Initiation Date
- December 29, 2021
- Termination Date
- December 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 792 bottles
Product Description
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
Reason for Recall
Superpotent and Failed Tablet/Capsule Specifications
Distribution Pattern
Nationwide in the US
Code Information
Batch # PF4520028B & PF4520028A, Exp. Date 11/2022