Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling

From Drugs.com - January 10, 2018

Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling

Audience: Pharmacy, Patient

[Posted 01/10/2018]

ISSUE: International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel Tablets USP, 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.

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.

BACKGROUND: Clopidogrel Tablets USP 75 mg are a platelet inhibitor (blood thinner) indicated for the use in patients with acute coronary syndrome, recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke.

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