August 2021 FDA Recall Clopidogrel by Macleods Pharma Usa Inc
D-0787-2021 - Presence of foreign matter
This Class II drug recall was voluntarily initiated by Macleods Pharma Usa Inc on August 2, 2021 for the product Clopidogrel. The FDA reported the reason for recall as presence of foreign matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0787-2021
Presence of foreign matter
08-02-2021
09-08-2021
444,000 tablets / 888 unit packs of 500 count
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.
Macleods 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.
Product was distributed nationwide.
12-02-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
