Drug recall D-0838-2020

Class III Terminated reported Feb 12, 2020

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

Reason for recall

Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.

Lots and codes

Lot# BPA5903A, EXP 05/2021; BPA5819A, EXP 11/2020

Recall details

Recalling firm
Macleods Pharma Usa Inc, Plainsboro, NJ
Quantity
4694 30x60-count bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
January 24, 2020
Terminated
December 16, 2022

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