Pioglitazone Tablet
FDA Recall NDC 33342-054
Latest: Class II · Status: Terminated · Initiated Sep 23, 2019 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pioglitazone (NDC 33342-054). A significant event, classified as Class II, was initiated on Sep 23, 2019 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Superpotent"
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 II Terminated
Superpotent
Sep 23, 2019
Oct 23, 2019
31,968 bottles
Recall Profile & Regulatory Data
Event ID
83960
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was shipped to 8 distributors who may have further distributed the product.
Termination Date
Feb 23, 2021
Product Description
Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India NDC 33342-054-07
Batch or Lot Expiration Information
Lot# BPF901A, exp. date 12/2021
Affected Packages Involved in this Recall
33342-054-07Pioglitazone
33342-054-10Pioglitazone
33342-054-15Pioglitazone
33342-054-12Pioglitazone
33342-055-07Pioglitazone
33342-055-10Pioglitazone
33342-055-15Pioglitazone
33342-055-12Pioglitazone
33342-056-07Pioglitazone
33342-056-10Pioglitazone
33342-056-15Pioglitazone
33342-056-12Pioglitazone
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.
