Indian drug makers Sun Pharmaceuticals and Ranbaxy Laboratories have recalled batches of their generic diabetes and cholesterol medicines respectively, after the companies received complaints of unrelated medication found in sealed bottles.
Mumbai-based Sun Pharmaceuticals (BOM:524715) recalled a batch of its generic version of Glumetza after epilepsy medication was found in a batch of the diabetes drug bound for the U.S. market. The recalls list on the website of U.S. Food and Drug Administration, or USFDA, for the week ending March 5 also included Ranbaxy Laboratories (BOM:500359), which recalled two batches of its generic version of cholesterol drug Lipitor, following reports of an unrelated dosage of the medicine in sealed bottles.
Sun Pharmaceuticals voluntarily recalled 2,528 bottles of metformin hydrochloride manufactured in April 2013, after a customer notified the presence of gabapentin drugs, which are used to cure seizures, in his bottle.
“Sun Pharma is examining the issue, and would not have anything specific to share beyond the announcement that the US FDA has made,” the company reportedly said in a statement, according to Mint, a local newspaper.
Ranbaxy Laboratories, which has been banned by the FDA from exporting medicines to the U.S. from three of its manufacturing units in India and paid about $500 million in fines last year, recalled 64,626 bottles of its copies of Lipitor after a pharmacist complained of a 20-milligram pill in a sealed 10-milligram bottle, according to FDA. This is the second recall for its atorvastatin drug in the last 15 months.
“Ranbaxy is proactively recalling the lots out of an abundance of caution, keeping the safety of its patients in mind and with the full knowledge of the US FDA,” the company, which is based near New Delhi, reportedly said, according to Mint.
In February, FDA Commissioner Margaret Hamburg had visited India and discussed manufacturing quality with 16 local drug companies. She also announced that the FDA would conduct workshops to better communicate the quality standards the agency expects from Indian drug makers. Indian pharmaceutical companies account for half of the warning letters issued by the FDA across the world.