Warning for counterfeit drugs simvastatin and carisoprodol recently imported from Mexico

Jul 31 2004

The U.S. Food and Drug Administration has issued a public warning regarding counterfeit versions of the drugs simvastatin and carisoprodol that have recently been imported from Mexico to the U.S.

Simvastatin is used with diet changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol and certain fatty substances in your blood. Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats may help to prevent heart disease, angina (chest pain), strokes, and heart attacks.

Carisoprodol, a muscle relaxant, is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries.

Tests have indicated that the counterfeit simvastatin did not contain any active ingredient and that the counterfeit carisoprodol differed in potency when compared to the authentic product. Carisoprodol is a drug used in the treatment of painful musculoskeletal conditions and Zocor is a cholesterol lowering drug. The counterfeit versions were reportedly purchased at Mexican border town pharmacies and sold under the names Zocor, 40/mg, (lot number K9784, expiration date November 2004), and Carisoprodol, 350/mg, (lot number 68348A). Patients who rely on these counterfeit versions of the drugs could develop serious health risks (with the counterfeit Zocor) or have insufficient pain relief (with the counterfeit carisoprodol).

FDA has repeatedly expressed its concern about the purchase by Americans of drugs from foreign countries. As demonstrated by this incident, purchasers cannot assume that the products meet the quality, efficacy, and safety standards of FDA authorized products or that FDA is assuring the quality, safety, and efficacy of products purchased from outside the United States.

Medications purchased within the US system for prescription drugs have undergone rigorous testing and review to verify their identity, potency, and purity and to ensure that they are safe and effective for their intended use. In addition, there are safeguards to help maintain the integrity of the products while in shipment to pharmacies and prior to dispending to patients.

Anyone who may have recently purchased the above described versions of Zocor 40/mg and Carisoprodol 350/mg from Mexican pharmacies should consult with their physician as well as notify their local FDA field office.

FDA is investigating this matter and working with the Mexican authorities to ensure that further sale and importation of these products is halted.