The Food and Drug Administration has ordered the recall of Batch No. C-174005 of Clopidogrel 75 mg Film-Coated Tablets after laboratory tests found that it may deliver a lower-than-intended dose of the active ingredient. Photo courtesy of FDA.
A batch of Clopidogrel 75 mg tablets is being pulled from the market after laboratory tests showed it may contain a lower-than-intended dose of its active ingredient, potentially reducing the medicine’s effectiveness, the Food and Drug Administration warned.
The FDA placed Batch No. C-174005 of Clopidogrel 75 mg Film-Coated Tablets under a Class I recall up to the retail level, ordering distributors, hospitals, pharmacies and retailers to stop its distribution, sale and use.
Laboratory analyses found that the batch failed approved specifications for assay and uniformity of dosage units, according to FDA Advisory No. 2026-0930 dated Aug. 13.
The agency said the problem could result in patients receiving less of the active ingredient than intended, potentially compromising the drug’s ability to protect them against heart attack and stroke.
Clopidogrel is used to prevent atherothrombotic events. It may also be given with aspirin to certain patients with moderate to high-risk transient ischemic attack or minor ischemic stroke, as well as those with atrial fibrillation.
The recall specifically covers Batch No. C-174005, manufactured in October 2024 and carrying a September 2027 expiration date. Its registration number is DRP-11057.
The affected medicine was manufactured by Centurion Laboratories Pvt. Ltd. in India, imported by Philgen Pharmaceuticals Inc. and distributed by Harlem Sales in Davao City. Consumers were advised not to purchase or use products belonging to the recalled batch.
The FDA also directed local governments and law enforcement agencies to ensure the affected batch is no longer available in their jurisdictions and urged patients to immediately report suspected adverse reactions associated with the medicine.