Drug Safety Alerts

Clopidogrel 75 mg tablets - Consumer-level Recall

1/10/18

On January 10, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level 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 clopidogrel 75mg or simvastatin 10 mg tablets. Missed doses of clopidogrel increases the risk of heart attack and stroke which can be life threatening. Patients should not stop taking clopidogrel without talking to their prescribing physician. Additionally, unintentional consumption of simvastatin could include the common side effects associated with its use and may cause fetal harm when administered to a pregnant woman. Simvastatin occasionally causes myopathy which is a disease of the muscles. Finally, allergic reactions are also possible and could also be life threatening. International Laboratoriesalso reports that to date, no complaints have been received related to this event detailing medical illnesses or harmful effects.

This recall affects lot number 117099A. No other lots are affected by this recall.

Consumers should contact their physician or healthcare provider if they are experiencing any health concerns that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program.

CVS Caremark Response: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Inmar at 1‑855‑258‑7280, Monday through Friday, 9:00 am to 5:00 pm (ET). You may also contact the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1‑888‑463‑6332) or visit https://www.fda.gov/.