Why it was recalled
Presence of foreign matter
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
Lot numbers, UPCs & expiration codes
Lot # BCA82021A, Exp 06/2023
Where it was sold
Product was distributed nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0787-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 2, 2021
- FDA report date
- Sep 8, 2021
- Quantity
- 444,000 tablets / 888 unit packs of 500 count
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-0787-2021, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88391
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- Lot # BCA82021A, Exp 06/2023
- Postal code
- 08536-0009
- Report date
- Sep 8, 2021
- Product type
- Drugs
- Recall number
- D-0787-2021
- Classification
- Class II
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 444,000 tablets / 888 unit packs of 500 count
- Termination date
- Dec 2, 2022
- Reason for recall
- Presence of foreign matter
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Aug 2, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 31, 2021