January 2020 FDA Recall Pioglitazone And Metformin Hydrochloride by Macleods Pharma Usa Inc
D-0838-2020 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Macleods Pharma Usa Inc on January 24, 2020 for the product Pioglitazone And Metformin Hydrochloride. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0838-2020
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
01-24-2020
02-12-2020
4694 30x60-count bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Macleods Pharma Usa Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
12-16-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# BPA5903A, EXP 05/2021; BPA5819A, EXP 11/2020
