FDAClass IIIFebruary 12, 2020

Pioglitazone and Metformin Hydrochloride Tablets recall: Subpotent

Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro…

Why was Pioglitazone and Metformin Hydrochloride Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro…
Recalling firm
Macleods Pharma Usa Inc
Quantity
4694 30x60-count bottles
Distribution
Nationwide
Recall date
February 12, 2020
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls