Ranbaxy Laboratories’ Update on USA Atorvastatin Recall.
The company says :
“We are working with the U.S. FDA, and have identified and implemented multiple corrective and preventative actions (CAPA). As part of the first step in initiating the manufacturing process to resume supplies to the U.S. market, we have commenced the production of the drug substance for our Atorvastatin 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 this product in other markets across the world.
At Ranbaxy, we are committed to patient safety and we remain confident in the continuing safety and quality of the drug products delivered to all of our customers worldwide.”
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