Recalls / Class II
Class IID-0787-2021
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
- Brand name
- Clopidogrel
- Generic name
- Clopidogrel
- Active ingredient
- Clopidogrel Bisulfate
- Route
- Oral
- NDC
- 33342-060
- FDA application
- ANDA202928
- Affected lot / code info
- Lot # BCA82021A, Exp 06/2023
Why it was recalled
Presence of foreign matter
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 444,000 tablets / 888 unit packs of 500 count
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2021-08-02
- FDA classified
- 2021-08-31
- Posted by FDA
- 2021-09-08
- Terminated
- 2022-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0787-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.