Pioglitazone Tablet
FDA Recall NDC 57237-219
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pioglitazone (NDC 57237-219). A significant event, classified as Class II, was initiated on Dec 29, 2021 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Superpotent and Failed Tablet/Capsule Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2021 Class II Recall: Superpotent and Failed Tablet/Capsule Specifications
Recall Number
Class II Terminated
Superpotent and Failed Tablet/Capsule Specifications
Dec 29, 2021
Feb 02, 2022
792 bottles
Recall Profile & Regulatory Data
Event ID
89323
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Dec 04, 2023
Product Description
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
Affected Packages Involved in this Recall
57237-219-30Product
57237-219-90Product
57237-219-05Product
57237-220-30Product
57237-220-90Product
57237-220-05Product
57237-221-30Product
57237-221-90Product
57237-221-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
