Glass particulates spur recall of generic drugs

A manufacturer of generic versions of the cholesterol medication Lipitor has announced that it will halt production of the drug after learning that several lots may have been contaminated with small glass particulates. No injuries have been reported as a result of the defective products, but the company says that it is possible that “adverse experiences arising primarily due to physical irritation” could result from the glass contamination. Therefore, the company says, the recall and the halted production are precautionary at this point.

According to a release from drug manufacturer Ranbaxy, the company is recalling 41 lots of atorvastatin, the generic form of Lipitor. The recall was instituted after company officials learned that some of the pills distributed in those lots contained small glass particles. Although the glass bits are reportedly less than 1 mm in size, they certainly pose a risk of harm to those that take the drug.

Ranbaxy is not yet sure how and why the glass particles got into the pills. As such, another reason for the recall is to find the cause of the contamination. Therefore, Ranbaxy says that it is halting production of atorvastatin altogether until the company has “thoroughly investigated the cause of the glass particulates and remedied the problem.”

The recall includes bottles of 90 and 500 tablets in doses ranging from 10 to 40 mg. The expiration dates on the recalled drugs are July 31 and August 31, 2014. A full list of recalled lots is available on the FDA website.

If you are taking atorvastatin and believe that you have been injured by the drug, it is important to save the product and keep a record of all information about the product and the injuries you suffered as a result of taking it. If you decide to file a personal injury lawsuit against the manufacturer, these items will be necessary for your case.

Source: MedPage Today, “Ranbaxy Pulls Defective Generic Lipitor,” John Gever, Nov. 29, 2012