We are working with the U.S. FDA, and have identified and implemented multiple corrective and preventative actions (CAPA) to significantly reduce the recurrence of such issues in the future. As part of the first step in initiating the manufacturing process, we have initiated the production of key raw materials for our product.
In November 2012, Ranbaxy Pharmaceuticals Inc., the U.S. subsidiary of Ranbaxy Laboratories Limited, had initiated a voluntary recall for select batches and strengths of Atorvastatin calcium tablets only in the U.S.A. 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 U.S. FDA.
Atorvastatin calcium tablets or any other product containing this molecule distributed outside the U.S. was not and is not affected in any way by this recall and Ranbaxy continues to supply in other markets across the world.
At Ranbaxy, our focus is on patient safety and we remain confident in the continuing safety and quality of the drug products delivered to all of our customers.