Ranbaxy, the maker of the generic version of the popular drug Lipitor (atorvastatin), recently announced that it will stop producing the drug after discovering that several lots may have been contaminated with small bits of glass. According to the Food and Drug Administration, Ranbaxy had found that some pills contained glass particles that were less than 1 millimeter in size.
While the company and the FDA have not received any reports of users experiencing adverse effects, stopping production was a necessary precaution. Through a statement, Ranbaxy explained that “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.”
While the company only spoke in terms of possibilities, having small glass shards passing through one’s system cannot be good.
The FDA also announced that it would work with other manufacturers of the drug, along with distributors to make sure that the affected products do not harm consumers. The Administration also announced that no shortages are likely since other companies produce the drug, and Pfizer still manufactures the original
Drug manufacturers, like makers of other mass produced products, have a duty to make sure that their products are safe for their intended uses. They could be held liable for distributing products that are defective (either through design, the way they are manufactured, or through improper warnings). Here, Ranbaxy could be liable for including glass particles in its products should consumers be harmed.
Source: Medpagetoday.com, Ranbaxy Pulls Defective Generic Lipitor, November 29, 2012