Large Quantity of Generic Lipitor Recalled

Ranbaxy Pharmaceuticals recalls generic Lipitor after contamination concerns

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Ranbaxy Pharmaceuticals Inc. has announced a large-scale recall of atorvastatin calcium, the generic form of the popular cholesterol medication, Lipitor, because it may be contaminated with tiny pieces of glass.

The recall of the 10, 20 and 40 milligram strengths was just announced, though the company began the recall on November 9. The voluntary retail-level recall includes 41 lots of medication, each containing thousands of pills. The 80 milligram generic doses are not affected by the recall.

"Do not discontinue medications without speaking to your doctor."

Ranbaxy officials said in a statement that the recall was a precautionary measure "due to the fact that we cannot exclude the possibility that the affected lots may contain very small glass particles resembling a fine grain of sand."

Since the particles of glass are very small, officials said it is unlikely to cause a serious safety concern. But the possibility of physical irritation from swallowing pills with tiny glass shards is possible, company officials admitted. As of yet, there are no reports of adverse events associated with the generic medication.

Ranbaxy has advised patients taking medication that may be affected to immediately consult with their doctor if they experienced issues while taking the drug. Distributors and retailers have been asked to return affected medication.

Atorvastatin calcium tablets are white, and imprinted with RX12 on 10 milligram tablets, RX828 on 20 milligram tablets and RX829 on 40 milligram tablets. Pill prescriptions for the drug typically contain 90 or 500 tablets in a plastic bottle. Ranbaxy offers an online listing of the lots affected so that consumers can check whether medication in their possession was affected.

The company will no longer manufacture the medication until the source of the potential contamination can be determined.

In the meantime, US Food and Drug Administration officials are monitoring the situation to ensure the recall will not affect the available supply of generic Lipitor.

"While there is no anticipated drug shortage for any of the affected lots or strengths, the FDA is proactively monitoring the situation for the possibility of a shortage," FDA officials said in a statement. "The FDA is working with other manufacturers of atorvastatin to ensure adequate market supply in order to avoid shortages of atorvastatin as a result of this ongoing recall."

Reviewed by: 
Review Date: 
November 29, 2012
Last Updated:
December 3, 2012