International Laboratories announced a voluntary recall of 1 lot of Clopidogrel Tablets, USP, 75mg, packaged in 30-count bottles due to mislabeling.
The product, while labeled Clopidogrel Tablets USP 75mg, may contain either Clopidogrel 75mg or Simvastatin Tablets USP 10mg. The Clopidogrel Tablets are light-pink to pink in color and are capsule shaped whereas the Simvastatin Tablets are light-pink and round in shape.
If a patient misses doses of clopidogrel, the risk of heart attack and stroke are increased. Accidental consumption of simvastatin can cause adverse effects (eg, myopathy) and fetal harm if taken by a pregnant woman. Moreover, a patient may experience allergic reactions that may be life-threatening.
Clopidogrel, an antiplatelet, is indicated for use in patients with acute coronary syndrome, recent myocardial infarction, recent stroke, or established peripheral arterial disease. Simvastatin, an HMG-CoA reductase inhibitor, is indicated for use in various hypercholesterolemia and dyslipidemia conditions.
The affected product (Lot #117099A) was distributed to centers in Arkansas, Georgia, Indiana, California, and Maryland, as well as to retail stores in all states. The Company is arranging for return of all recalled products.
For more information call (855) 258-7280 or visit InternationalLabs.com.