Drug product
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
D-0838-2020
Product summary
- Event
- Event 84754
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4694 30x60-count bottles
- Official record key
drug-enforcement:D-0838-2020
Official wording
Reason: Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Code information: Lot# BPA5903A, EXP 05/2021; BPA5819A, EXP 11/2020
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent