Clopidogrel Tablets Recalled for Foreign Matter Contamination
Macleods Pharma USA is recalling Clopidogrel 75 mg tablets due to the presence of foreign matter in the product. The affected lot was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text states only the presence of foreign matter without reporting any actual illnesses, injuries, or deaths. Foreign matter contamination in a pharmaceutical product is a safety concern that warrants recall, but without confirmed adverse health outcomes it does not meet the threshold for a higher severity rating.
Plain-English summary
Macleods Pharma USA Inc is recalling Clopidogrel (Clopidogrel Bisulfate) Tablets, USP, 75 mg, in 500-count bottles due to the presence of foreign matter in the product.
The recalled product is Lot # BCA82021A with expiration date 06/2023. This lot comprised approximately 444,000 tablets across 888 unit packs and was distributed nationwide. The product is manufactured by Macleods Pharmaceutical Ltd. in Baddi, Himachal Pradesh, India, and is distributed by Macleods Pharma USA, Inc., located in Plainsboro, NJ 08536. The relevant NDC number is 33342-060-15.
Clopidogrel is a prescription oral antiplatelet medication. Patients currently taking this medication should contact their healthcare provider if they have concerns or questions about the safety of their supply. Healthcare providers and pharmacies should quarantine and return affected product to the recalling firm.
The recalled product
- Product
- CLOPIDOGREL (CLOPIDOGREL)
- Brand
- CLOPIDOGREL
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Antiplatelet
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # BCA82021A
- Exp 06/2023
UPCs (3)
- 0333342060440
- 0333342060075
- 0333342060105
Distribution
Distributed nationwide across the United States.
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