Simvastatin Recall Issued by Dr. Reddy’s

About 60,000 bottles of generic Zocor (simvastatin) have been recalled by Dr. Reddy’s due to a musty odor caused by contaminants. 

The simvastatin recall was announced earlier this month in an FDA enforcement report, affecting some 10 mg and 40 mg bottles of the generic cholesterol drug after consumers complained of moldy and musty odors. The FDA reported that trace amounts of the pesticide 2,4,6-tribromoanisole (TBA), and similar contaminants were detected in the recalled batches.

The recall affects one lot of 10 mg, 500-count bottles of simvastatin with lot # C008115 with an expiration date of 11/12 and NDC 55111-198-05. The recall also includes six lots of 40 mg, 90-count bottles of simvastatin with lot numbers C008195, C008196, C008198 and C008200 with an expiration date of 11/13 and NDC 55111-200-90; as well as 40 mg, 500-count bottles with lot numbers C008197 and C008199 with an expiration date of 11/13 and NDC 55111-200-05. All of the recalled generic Zocor pills were manufactured at Dr. Reddy’s Mexico production plant.

A recall of simvastatin 80 mg doses was issued by Dr. Reddy’s last December for about 26,000 bottles due to similar problems, the enforcement report stated.

TBA is a pesticide used to treat wooden pallets and has been responsible for a number of drug recalls in recent years. Johnson & Johnson over-the-counter products, like Tylenol, have been particularly hard hit by TBA odor recalls. In some previous recalls, consumers have reported suffering gastrointestinal illness after taking the contaminated pills.

Zocor (simvastatin) is a synthetic statin developed by Merck & Co., which is widely available as generic simvastatin from a number of different drug makers, including Dr. Reddy’s. Before patent protections expired in 2005, it was Merck’s best-selling drug and the second best selling cholesterol lowering drug in the world, bringing in $4.3 billion in 2005.

In June, the FDA placed restrictions on the use of 80 mg Zocor, which could include twice-a-day 40mg doses, due to the risk of myopathy and rhabdomyolysis, a potentially life-threatening muscle injury.

Rhabdomyolysis from Zocor causes muscle fibers to begin to break down, releasing a protein called myoglobin, which can damage the kidneys as they attempt to filter it out of the bloodstream. Symptoms of rhabdomyolysis include muscle cramps, tenderness, stiffness, pain or spasms. The illness is usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism.