Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., E...

FDA Recall #D-0450-2022 — Class II — December 29, 2021

Recall #D-0450-2022 Date: December 29, 2021 Classification: Class II Status: Terminated

Product Description

Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05

Reason for Recall

Superpotent and Failed Tablet/Capsule Specifications

Recalling Firm

Aurobindo Pharma USA Inc. — East Windsor, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

792 bottles

Distribution

Nationwide in the US

Code Information

Batch # PF4520028B & PF4520028A, Exp. Date 11/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated