Lot #117099A of clopidogrel tablets, USP 75 mg, has been voluntarily recalled by International Laboratories, LLC (St. Petersburg, FL) because of mislabeling.
The product is labeled as clopidogrel tablets USP 75 mg, but may contain either clopidogrel 75 mg or simvastatin tablets USP 10 mg. This lot was distributed nationwide, including distribution centers in Arkansas, California, Georgia, Indiana, and Maryland.
Clopidogrel is a platelet inhibitor indicated for use in acute coronary syndrome, recent myocardial infarction, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce myocardial infarction and stroke rates.
All distributors and customers will be notified by letter and International Laboratories, LLC, will arrange for return of all recalled products. The company advises consumers to stop using the product and return it for a refund. In addition, if patients experience any health concerns, they should contact their healthcare provider.
For more information or to submit an adverse event report, please visit the US Food and Drug Administration’s MedWatch site.
International Laboratories, LLC issues voluntary nationwide recall of one (1) lot of clopidogrel tablets USP, 75 mg packaged in bottles of 30 tablets due to mislabeling NDC # 54458-888-16; lot # 117099A [press release]. Silver Spring, MD: US Food and Drug Administration. January 10, 2018. Accessed January 10, 2018.