One lot of clopidogrel 75 mg tablets in 30-count bottles may contain either clopidogrel 75 mg tablets or simvastatin 10 mg tablets; therefore, International Laboratories, LLC is voluntarily recalling lot # 117099A. Clopidogrel is a platelet inhibitor used in patients with acute coronary syndrome, myocardial infarction, peripheral arterial disease, or stroke to reduce the incidence of further events. Missing clopidogrel doses can increase the risk of cardiovascular events. Additionally, patients unknowingly taking simvastatin may experience allergic reaction, side effects (eg, myopathy), or fetal harm in pregnancy. International Laboratories, LLC has not received any reports of harm to date.
Patients should return tablets to the location of purchase for a refund, and contact their health care provider if they have any concerns. Patients and providers can call (Inmar at 855-258-7280), email (internationallabs@inmar.com), or use physical mail (Recall Coordinator 635 Vine St. Winston Salem, NC 27101) with questions about the recall.
Consumers should report any adverse reactions experienced from this product to their provider and the FDA MedWatch Adverse Event Reporting Program online at: www.fda.gov/medwatch/report.htm
Additional information is available at the following links: