Ranbaxy Inc. voluntarily recalled 41 lots of Atorvastatin calcium tablets in 10-mg, 20-mg, and 40-mg doses because of potential contamination with ground glass, the company and the Food and Drug Administration announced Nov. 28.
The small size of the particles (less than 1 mm) makes safety concerns unlikely, according to the statement from MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
"However, the possibility of adverse experiences arising primarily due to physical irritation cannot be ruled out," according to the statement.
The recall does not affect the 80-mg dosage of Atorvastatin calcium tablets, according to the Ranbaxy company press release, which lists the specific lots included in the recall.
Ranbaxy initiated the recall on Nov. 9. Distributors have ceased distribution of the affected lots and are in the process of returning these products to Ranbaxy, according to the statement. The affected tablet is white in color, with the imprint RX12 on 10-mg tablets, RX828 on 20-mg tablets, and RX829 on 40-mg tablets.
Atorvastatin is prescribed not only for lowering blood cholesterol, but also for the prevention of cardiovascular disease in patients at high risk for cardiovascular conditions, and for the prevention of cardiovascular events in patients with heart disease.
Adverse reactions or quality problems with the affected atorvastatin lots may be reported to the FDA online, by mail (use Form FDA 3500), or by fax (1-800-FDA-0178).