Generic Plavix Recalled Due to Mislabeling

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
Posted on

Manufacturer International Laboratories LLC has issued a voluntary recall of one lot of clopidogrel, the generic for Plavix.

This is a class II recall, the most common type of recall, which means that there is a situation where the use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.

What is clopidogrel indicated for?

Clopidogrel is an anti-platelet medication indicated for acute coronary syndrome, recent heart attack, recent stroke, or established peripheral artery disease.

Clopidogrel keeps your blood cells “slippery” so that they don’t stick together and cause a blood clot.

Why was clopidogrel recalled?

The manufacturer, International Laboratories LLC, has issued a nationwide voluntary recall of clopidogrel, with the knowledge of the FDA, due to product mislabeling.

The bottles are labeled as clopidogrel 75 mg tablets but may contain simvastatin 10 mg tablets. Taking mislabeled clopidogrel can potentially cause a heart attack or stroke, or serious life-threatening side effects.

Which clopidogrel products were recalled?

According to the FDA’s announcement, the affected products were distributed nationwide and delivered to distribution in the following states: Arkansas, California, Georgia, Indiana, and Maryland.

The drug will affect bottles with an NDC code 54458-888-16 and lot number 117099A.

Have there been any adverse event reports to International Laboratories LLC from patients?

No. At this time, International Laboratories LLC has not received any reports of adverse events associated with this recall.

What has been done to alert those who may be affected?

International Laboratories LLC is notifying distributors and customers by letter and is arranging for return of all recalled products. Consumers who have purchased this product should stop using and return the product to the location of purchase for a full refund.

For questions regarding the return of product please call International Laboratories at 855-258-7280 or via email at internationallabs@inmar.com.

Always inspect your medications, including all parts of the packaging and devices. If you ever notice your medication doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. You can also notify the FDA’s MedWatch Reporting Program as they can conduct further necessary investigations.

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