Safety Alerts & Recalls

What does this mean?

Patients should not stop taking clopidogrel without talking to their prescribing physician. This alert is a good reminder to check with your pharmacist or doctor whenever your prescription medication looks different than the tablets or capsules usually dispensed to you.

International Laboratories, LLC, the maker of the recalled clopidogrel, is notifying distributors and customers by letter. They are also arranging for return of all recalled products.

If you think you have received this product or have questions about this recall, you can contact your pharmacy. Your pharmacy can help you determine if your medication is involved in the recall and provide instructions on how to return the product.

You should also contact your physician or healthcare provider if you are experiencing any health concerns that may be related to taking or using this clopidogrel.

Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: http://www.fda.gov/Safety/MedWatch/default.htm

Clopidogrel Tablets, 75 mg Recalled by International Laboratories

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

Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening. Additionally, unintended 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.

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

The product was distributed nationwide and delivered to the distribution centers in Arkansas, Georgia, Indiana, California and Maryland, and distributed to retail stores in all US States.

For more information, please visit: more information here

Source: FDA
Publication Date: 2018-01-31
Last Updated: 2018-01-31

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