The Food and Drug Administration (FDA) recently announced a recall involving atorvastatin, the generic version of the popular cholesterol reducing drug, Lipitor. According to a number of news reports, the drug was being recalled after some pills contained glass particles. The drug’s maker, Ranbaxy announced that it will stop producing atorvastatin while it completes an investigation to determine the source of the problem.
Drug manufacturers have a legal duty to ensure that their products are safe for their intended uses. They could be held liable for distributing products that are defective due to inadequate warnings about side effects (i.e. black box warnings) or issues with manufacturing. Finding glass shards in pills would subject Ranbaxy to civil liability should someone be injured or sickened.
The FDA reportedly has not received any accounts of users having any problems taking atorvastation due to the glass issues or otherwise. Nevertheless, Ranbaxy explained that halting production was a necessary precaution. It released a statement saying:
“Because of the size of the particles which may be present in the affected lots it is unlikely to cause a significant safety concern. However, the possibility of adverse experiences arising primarily due to physical irritation cannot be ruled out.”
Essentially, the particles were less than 1 millimeter in size. While the company only spoke in terms of potential harm, the human digestive tract was not necessarily designed to handle small pieces of glass.
In the meantime, the FDA announced that it would work with other manufacturers and distributors to make sure that consumers are safe from the affected products. The Administration also did not foresee any shortages, and said that the original Lipitor was not affected.
Source: Medpagetoday.com, Ranbaxy Pulls Defective Generic Lipitor, November 29, 2012