International Laboratories LLC is recalling one lot of the blood thinner Clopidogrel because the pills may contain the cholesterol-lowering statin Simvastatin instead. The recall affects Lot # 117099A of Clopidogrel Tabloets, USP 75mg, packaged in bottles of 30 tablets. The affected lot was delivered to distribution centers in Arkansas, Georgia, Indiana, California and Maryland, and then distributed to retail stores throughout the U.S.
Patients prescribed Clopidogrel, the active drug ingredient in Plavix, who miss doses of this medication are at an increased risk of heart attack and stroke, both of which can be life threatening. Additionally, unintentional consumption of Simvastatin, the active drug ingredient in Zocor, may experience side effects such as fetal harm in pregnant women, a disease of the muscles called myopathy, and potentially life threatening allergic reactions. To date, International Laboratories has received no reports of injuries related to this recall.
Clopidogrel is a platelet inhibitor to reduce the risk of heart attack or stroke patients with acute coronary syndrome, a recent heart attack or stroke, or with established peripheral artery disease. Simvastatin can treat high cholesterol and triglyceride levels and may reduce the risk of heart attack, stroke and related health conditions.
International Laboratories is notifying its distributors and customers and arranging for return of all recalled products. Consumers who have this product in their possession should stop using it and return it to the location of purchase for a full refund. Any adverse events related to this mislabeling issue should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Safety Communication