Ranbaxy Pharmaceuticals is voluntarily recalling certain lots of its atorvastatin calcium tablets.
The manufacturer of generic drugs announced that 10 mg, 20 mg and 40 mg dosage strengths of the generic statin, packaged in 90- and 500-count bottles, may contain small glass particles approximately less than 1 mm in size. The recall does not affect the 80 mg strength dosage, and the recall is being conducted at the retail level for select batches.
The company, on its U.S. website, said that it “is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind. This recall is being conducted with the full knowledge of the U.S. FDA.”
Ranbaxy Laboratories gained FDA approval Nov. 30, 2011, to develop generic atorvastatin calcium tablets. Ranbaxy has been criticized in the past for submitting what the FDA charged was falsified data; failing to meet FDA quality standards, which resulted in a five-month delay in the rollout of the generic Lipitor product; and for allegedly conspiring with Lipitor maker Pfizer to stall sales of the generic version of the statin.
Ranbaxy Pharmaceuticals is based in Jacksonville, Fla., and is a wholly owned subsidiary of Ranbaxy Laboratories Limited, India's largest pharmaceutical company.
A list of the affected lots is available here.