December 2021 FDA Recall Pioglitazone by Aurobindo Pharma Usa Inc.
D-0450-2022 - Superpotent and Failed Tablet/Capsule Specifications
This Class II drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on December 29, 2021 for the product Pioglitazone. The FDA reported the reason for recall as superpotent and failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0450-2022
Superpotent and Failed Tablet/Capsule Specifications
12-29-2021
02-02-2022
792 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Aurobindo 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 in the US
12-04-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
Batch or Lot Expiration Information
Batch# PF4520028B & PF4520028A, Exp. Date 11/2022
