Pioglitazone And Metformin Hydrochloride Tablet
FDA Recall NDC 33342-177
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 And Metformin Hydrochloride (NDC 33342-177). A significant event, classified as Class III, was initiated on Jan 24, 2020 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets."
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
Class III Terminated
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Jan 24, 2020
Feb 12, 2020
4694 30x60-count bottles
Recall Profile & Regulatory Data
Event ID
84754
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 16, 2022
Product Description
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
Affected Packages Involved in this Recall
33342-176-09Product
33342-176-11Product
33342-176-57Product
33342-176-44Product
33342-176-12Product
33342-177-09Product
33342-177-11Product
33342-177-57Product
33342-177-44Product
33342-177-12Product
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.
