International Laboratories is voluntarily recalling one lot of clopidogrel USP 75-mg tablets because it was mislabeled and may contain clopidogrel 75 mg or simvastatin USP 10-mg tablets, according to a US Food and Drug Administration (FDA) safety alert.
Patients are advised not to stop taking the antiplatelet medication without talking to their physician because missed doses of clopidogrel increase the risk for heart attack and stroke, which can be life-threatening, the FDA said in the alert, posted January 10.
Unintended use of the cholesterol-lowering drug simvastatin (Zocor, Merck) could include the common side effects associated with its use and may cause fetal harm if given to pregnant women, the alert notes. Simvastatin occasionally causes myopathy. Allergic reactions are also possible and could be life-threatening.
To date, no complaints detailing medical illness or harmful effects have been reported, according to the company.
The affected lot, #117099A, was packaged in bottles of 30 tablets and distributed nationwide. The company has notified consumers and distributors and asked consumers to stop using and return the product to the place of purchase for a full refund.
As previously reported, International Laboratories initiated another voluntary nationwide recall in August 2017 because a single lot of pravastatin sodium USP 40-mg tablets was mislabeled and instead contained the antidepressant bupropion.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of the clopidogrel tablets to the FDA's MedWatch Safety Information and Adverse Event Reporting program.
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Cite this: Clopidogrel Tablets Recalled, May Contain Simvastatin - Medscape - Jan 11, 2018.