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International Laboratories LLC is voluntarily recalling clopidogrel 75 mg tablets due to mislabeling concerns. This recall affects one lot of 30-count bottles (NDC 54458-888-16; Lot 117099A). This lot may contain simvastatin 10 mg tablets, but is labeled as clopidogrel 75 mg tablets. Clopidogrel is a platelet inhibitor (blood thinner) used to prevent heart attacks and stroke. Patients who miss doses of clopidogrel are at increased risk of these conditions. Simvastatin is a statin medication used to treat high cholesterol. Unintentional exposure can cause allergic reactions or symptoms of simvastatin side effects, including myopathy (muscle pain). Simvastatin may also cause fetal harm in pregnant women.
International Laboratories LLC has notified distributors and customers by letter to arrange the return of the mislabeled lot. Consumers with questions regarding this recall may contact Inmar by phone (855-258-7280) or email (internationallabs@inmar.com). Consumers should report any adverse reactions experienced from this product to their provider and the FDA MedWatch Adverse Event Reporting Program.
Additional information:
- MedWatch Safety Alert – January 10, 2018
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592047.htm - International Laboratories, LLC press release – January 10, 2018
www.fda.gov/Safety/Recalls/ucm591975.htm