Ranbaxy Laboratories has commenced the production of the drug substance for Atorvastatin product. The company has taken this step as part of first step in initiating the manufacturing process to resume supplies to the US market. The company is working with US Food and Drug Administration (USFDA) and has identified and implemented multiple corrective and preventative actions (CAPA).
In November 2012, Ranbaxy Pharmaceuticals Inc., the US subsidiary of Ranbaxy Laboratories, had initiated a voluntary recall for select batches and strengths of Atotvastatin calcium tablets only in the USA. The recall was for its 10mg, 20mg and 40mg dosage strengths, packaged in 90’s and 500 count bottles, and only with respect to certain select lot numbers. The recall did not affect or relate to the 80mg strength. Ranbaxy had proactively and voluntarily recalled the lots out of abundant caution, keeping the safety of its customers in mind and with the full knowledge of the USFDA.
Atorvastatin calcium tablets or any other product containing this molecule distributed outside the US was not and is not affected in any way by this recall and Ranbaxy continues to supply this product in other markets across the world.
