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Medication Safety Alerts

Clopidogrel 75 mg tablets - Voluntary Recall

January 10, 2018

On January 10, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of clopidogrel 75 mg tablets manufactured by International Laboratories. This recall was issued because manufacturer bottles that are labeled as Clopidogrel Tablets, USP 75mg may contain simvastatin 10 mg tablets. Missing a dose of clopidogrel could increase the risk of heart attack and stroke which could be life threatening. Accidently taking simvastatin could cause side effects and allergic reactions which could be life threatening.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

This recall affects lot number 117099A. If your prescription was dispensed in a manufacturer’s bottle, please check the lot number. The lot number is on the left-hand side of the manufacturer’s label by the bar code. If your product is not from lot number 117099A, it is not affected by this recall. If your product is from lot number 117099A, please contact the pharmacy that filled your prescription for further instructions.

If your prescription was dispensed in an amber pharmacy bottle, check to make sure your bottle does NOT contain Simvastatin 10mg tablets. Clopidogrel 75 mg tablets are pink, oblong-shaped tablets with “TV” on one side and "7314" on the other side. Simvastatin 10 mg tablets are pink, round-shaped tablets with “TV” on one side and "7153" on the other side. If you find Simvastatin 10mg tablets in your bottle, please contact the pharmacy that filled your prescription for further instructions.

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: This product is not carried by the CVS Caremark Mail Service Pharmacies. If you are currently taking clopidogrel 75 mg tablets, please call a Customer Care representative toll-free at 1-866-823-5184 for more information.

If you are currently taking clopidogrel 75 mg tablets and have questions regarding this recall, please call your doctor or call For more information, please call Inmar toll-free at 1-855-258-7280, Monday through Friday, 9:00 am to 5:00 pm (ET). You may also call the FDA consumer inquiry line toll-free at 1 888 INFO-FDA (1 888-463-6332) or visit their Web site at https://www.fda.gov/.

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