Ranbaxy Recalls Generic Atorvastatin

November 26, 2012

PRINCETON, New Jersey — Shortages of generic atorvastatin are possible in the US in the next few weeks after one of the major suppliers, Ranbaxy Laboratories, announced the recall of several batches of its product because they may contain glass particles.

In a statement, available on its website, Ranbaxy says it is conducting a voluntary recall for certain lot numbers of atorvastatin calcium tablets of 10 mg, 20 mg, and 40 mg, packaged in 90- and 500-count bottles. The recall does not affect the 80-mg strength. Lot numbers affected are listed on the website. It notes that these batches may contain a foreign substance (small glass particles approximately less than 1 mm in size). The company adds that it is "proactively recalling the drug product lots out of an abundance of caution and in keeping the safety of our customers in mind. This recall is being conducted with the full knowledge of the US FDA" [2].

Ranbaxy is also reported in various press articles to have started an investigation, which it says is expected to be completed in two weeks, when supplies should be resumed.

Ranbaxy had marketing exclusivity for generic atorvastatin during its first six months on the US market, during which time it generated sales of almost $600 million for the company. This period of exclusivity ended in May this year. Although the market has since opened up considerably, it is estimated that Ranbaxy has still held on to around 30% of generic atorvastatin sales.

This is the latest in a series of manufacturing problems and other issues, including claims of data falsification, at Ranbaxy factories. The FDA has already banned imports of 30 Ranbaxy products and vetoed the approval of any new Ranbaxy products until the company agreed to make improvements and be monitored by a third party for five years. The company has agreed to these conditions, but the current situation is leading to questions as to whether the manufacturing conditions have actually improved.

Editor's note: On November 29, the FDA announced that in addition to the company's recall of specific lots, "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" [3].