(c) 2014, Bloomberg News
MUMBAI, India - Ranbaxy Laboratories, India's largest drugmaker, has recalled two batches of the company's generic version of Pfizer's cholesterol-lowering medicine Lipitor after a dose mix-up was detected.
Ranbaxy, a unit of Tokyo-based Daiichi Sankyo, is pulling back pills in 64,626 bottles of atorvastatin calcium in the U.S. after a "product complaint" was received by a pharmacist, the U.S. Food and Drug Administration said on its website. The pharmacist had discovered a 20 milligram tablet in a sealed bottle marked for 10 milligram pills, the FDA said.
The nationwide recall comes on the back of increasing scrutiny on Ranbaxy, all four of whose Indian facilities are suspended from selling in the U.S. for failing to meet the FDA's current Good Manufacturing Practices. The drugmaker had previously called back its generic version of Lipitor pills in November 2012 for possibly containing small particles of glass.
"The actual recall happened in January this year," said Gaurav Chugh, a Ranbaxy spokesman, in an emailed statement Saturday on the "voluntary recall." "Other lot numbers, package sizes and strengths are not affected by this recall. Ranbaxy is proactively recalling the lots out of an abundance of caution, keeping the safety of its patients in mind."
Phone calls to the FDA switchboard outside normal business hours seeking comment went unanswered.
Ranbaxy shares have declined 18 percent this year in Mumbai trading, compared with a 3.5 percent increase for the benchmark S&P BSE Sensex. The shares fell 0.4 percent on Friday to close at 370.35 rupees.
U.S. FDA officials have said they plan to tighten rules for and be more transparent on how they regulate the generic drug industry as a way to persuade U.S. consumers that safeguards are in place. Generic drugs, which make up almost 80 percent of the medicine used in the U.S., helped Americans save $193 billion in 2011 as health-care costs rise and insurers force more consumers to use them.
Indian drugmakers, which supply a quarter of the medicines used in the U.S., must take responsibility for the quality of their cheaper medicines, Margaret Hamburg, the U.S. FDA commissioner, told Bloomberg TV India in a Feb. 18 interview.
"If a company wants to do business in the United States, the responsibility is on them to understand the rules and requirements," Hamburg said during an eight-day visit to India where she plans to expand the FDA's office, train local drug inspectors and step up plant inspections.
Ranbaxy, which was first cleared by U.S. regulators to sell copies of the cholesterol-lowering pill in 2011, had agreed to make changes at its manufacturing plants to address allegations that its pharmaceuticals didn't meet FDA standards, according to a proposed settlement filed by the Justice Department in January 2012. The company announced in December that year that it had told the FDA it would tighten procedures and policies to comply with industry standards.
In November 2012, Ranbaxy issued another voluntary recall of some lots of 10-milligram, 20-milligram and 40-milligram dosage strengths of atorvastatin tablets "due to possible contamination with very small glass particles similar to the size of a grain of sand," according to a statement on the U.S FDA website.
In January, U.S. FDA inspectors paid a surprise visit to the Ranbaxy plant in Toansa, a rural area north of New Delhi, and found broken equipment, windows stuck open and flies "too numerous to count," according to the FDA's report of its inspection. Workers ran quality tests repeatedly until they got the results they wanted, the regulator said.
Soon after visiting the Toansa factory, the FDA banned the export of drug ingredients from the facility to the U.S.