Drug 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
D-0787-2021
Product summary
- Event
- Event 88391
- Status
- Terminated
- Classification
- Class II
- Quantity
- 444,000 tablets / 888 unit packs of 500 count
- Official record key
drug-enforcement:D-0787-2021
Official wording
Reason: Presence of foreign matter
Code information: Lot # BCA82021A, Exp 06/2023
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Foreign material or chemical contamination
foreign matter