D-0838-2020 Class III Terminated
FDA drug recall D-0838-2020 was initiated by Macleods Pharma Usa Inc on January 24, 2020 and is designated Class III. Reason for recall: Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets. The recall status is terminated (terminated December 16, 2022). Affected quantity: 4694 30x60-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2020
- Initiation Date
- January 24, 2020
- Termination Date
- December 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4694 30x60-count bottles
Product Description
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09
Reason for Recall
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Distribution Pattern
Nationwide
Code Information
Lot# BPA5903A, EXP 05/2021; BPA5819A, EXP 11/2020