Earlier in November, Ranbaxy Pharmaceuticals conducted a voluntary recall of their Lipitor generic formulation drug, atorvastatin calcium pills. This generic formulation of Lipitor is one of the most prescribed medications within the senior community. Ranbaxy Pharmaceuticals is a United States subsidiary of Ranbaxy Laboratories Limited, which is located in India. The official reason for the recall is due to the discovery of glass particles within many lots of the drug.
The drugs involved in this recall are the 10mg, 20mg and 40mg formulations. Each lot of these formulations were packaged in 90 and 500 count bottles.
Ranbaxy Pharmaceuticals stressed to the public that only certain lot numbers were found to be tainted and that the 80mg strength of generic Lipitor was not involved in the voluntary recall. Weeks after the initial mass recall, Ranbaxy Laboratories temporarily stopped all manufacturing of atorvastatin while they attempted to discover the root of the problem. As of yet, there are no reports of patient injury due to the glass particles. So, what does this mean for the high number of seniors who take atorvastatin on a daily basis?
The United States Food and Drug Administration (FDA) is monitoring the situation and working with Ranbaxy Pharmaceuticals to ensure that all safety precautions are being followed. In addition, the FDA will oversee the recall process and work closely with Ranbaxy Pharmaceuticals to resolve its quality manufacturing issues. This recall is the most recent manufacturing problem for Ranbaxy. They were already under the microscope of scrutiny because of previous quality control problems.
The FDA does not foresee a shortage of atorvastatin, as several other companies also produce the generic formulation of Lipitor and Pfizer continues to manufacture its original branded version, Lipitor. They are also working with other manufacturers as a precaution to avoid potential shortages of atorvastatin as a result of the mass recall.
For detailed information on the list of recalled products and lot numbers which are affected, visit the Ranbaxyusa.com website.