Ranbaxy Pharmaceuticals has decided to stop manufacturing atorvastatin until it has thoroughly investigated the cause of quality issues and remedied the problem, the FDA announced Nov. 29.
Jacksonville, Fla.-based Ranbaxy informed its customers of a voluntary recall of certain lots of the company’s 10 mg, 20 mg, and 40 mg dosage strengths of atorvastatin tablets. The lots of atorvastatin, packaged in 90- and 500-tablet bottles, are being recalled due to possible contamination with very small glass particles less than 1 mm in size.
The FDA said that based on the information from Ranbaxy and from the FDA’s initial assessment, the possibility of adverse events related to the recalled product appear to be low, and that if any adverse events are experienced, they would be temporary. The agency said it has not received any reports of patient harm due to glass particulates that may be in the recalled product.
Consumers who are concerned that they may have received a recalled product should consult with their pharmacist where they bought the product to confirm whether they received a recalled product, should stop taking the product if it was recalled, and should consult with their pharmacist or physician about how to obtain an alternative product.
A list of the affected lots is available here.