Ranbaxy Issues Voluntary Recall of Atorvastatin Due to Quality Issues

Ranbaxy Pharmaceuticals has issued 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 bottles of 90 and 500 tablets, are being recalled due to possible contamination with small glass particles (less than 1 mm in size), according to a Nov. 29, 2012 statement by FDA.

Ranbaxy received FDA approval of its abbreviated new drug application to market the generic version of atorvastatin in November 2011. Atorvastatin is the active ingredient in Pfizer’s anticholesterol drug Lipitor, which was the top-selling prescription drug in 2011, with sales of $12.5 billion, according to IMS Health. Pfizer lost US patent exclusivity for Lipitor in November 2011.

According to the FDA statement, Ranbaxy has decided to stop manufacturing atorvastatin until it has thoroughly investigated the cause of the glass particulates and remedied the problem. “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 if any adverse events are experienced, they would be temporary,” according to the FDA statement. FDA said it has not received any reports of patient harm due to glass particulates that may be in the recalled product.

The FDA statement did not specify the manufacturing facility at which the affected lots were manufactured. In April 2012, Ranbaxy Laboratories reported that it had begun exports of atorvastatin calcium oral tablets to the US market from its Mohali SEZ manufacturing facility, located in Punjab, India, according to an Apr. 2, 2012, Ranbaxy press release. In April 2012, Ranbaxy said the supply of atorvastatin tablets from India supplemented the company’s production from Ohm Laboratories Inc. USA.

In its statement, FDA says while there is no anticipated drug shortage for any of the affected lots or strengths, FDA is proactively monitoring the situation for the possibility of a shortage. FDA is working with other manufacturers of atorvastatin to ensure adequate market supply to avoid shortages of atorvastatin as a result of this ongoing recall.

The specific lots that were recalled are specified here.