Clopidogrel Tablet
FDA Recall NDC 33342-060
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 Clopidogrel (NDC 33342-060). A significant event, classified as Class II, was initiated on Aug 02, 2021 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Presence of foreign matter"
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
Presence of foreign matter
Aug 02, 2021
Sep 08, 2021
444,000 tablets / 888 unit packs of 500 count
Recall Profile & Regulatory Data
Event ID
88391
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide.
Termination Date
Dec 02, 2022
Product Description
Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical Ltd., Baddi, Himachal, Pradesh, INDIA NDC 33342-060-15
Batch or Lot Expiration Information
Lot# BCA82021A, Exp 06/2023
Affected Packages Involved in this Recall
33342-060-07Product
33342-060-15Product
33342-060-12Product
33342-060-10Product
33342-060-44Product
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.
