The drug maker, Ranbaxy Laboratories, Inc., has voluntarily recalled more than 40 lots of its generic version of the widely prescribed cholesterol-lowering drug, Lipitor, from the U.S. market after finding small glass particles in some batches.
Ranbaxy, an Indian company of Japan’s Daiichi Sankyo Co., with U.S. offices in Jacksonville, Florida, and manufacturing facilities in New Jersey, said the voluntary action would cause a temporary supply disruption, but the company says they expect to complete an investigation within two weeks and resume shipments thereafter.
The U.S. Food and Drug Administration (FDA) said the recall could lead to a shortage of atorvastatin, the generic name for Lipitor. “We are doing everything we can to mitigate a shortage, including reaching out to other manufacturers,” said Sarah Clark-Lynn, an FDA spokesperson. “We’re monitoring the situation.”
The FDA said it wasn’t aware of any reports of injuries or deaths tied to the recalled product and did not say how the problem was discovered.
Ranbaxy was the first company to begin selling generic Lipitor a year ago, under the terms of a prior settlement of patent litigation with Pfizer Inc., which makes branded Lipitor. Pfizer’s U.S. market exclusivity for the blockbuster branded drug expired, making it possible for multiple manufacturers to produce low-cost generic copies.
Pfizer also had lost its exclusivity for Lipitor in other countries. Its branded Lipitor sales declined 56 percent to $3.36 billion the first nine months of 2012.
“Ranbaxy is proactively recalling the drug product out of an abundance of caution,” the company said. The recall is being conducted “with the full knowledge of the FDA,” which granted the company its approval to manufacture the drug at a plant in New Jersey in 2011.
Clark-Lynn said the agency is “working with the company to address their quality issues” and patients who have already consumed drugs from the affected batches and are concerned about their safety should contact a physician.
Ranbaxy’s generic Lipitor sales covered 44 percent of the U.S. market for the drug, including branded and generic products, as of October, said Ross Muken, an analyst at ISI Group LLC. Watson Pharmaceuticals, Inc., a competitor, will “most certainly” benefit from the recall, Mr. Muken said. Pfizer supplies Watson’s version of the drug.
Ranbaxy said Friday that it is conducting a retail-level recall of certain lots of the 90 and 500 pill bottles of atorvastatin, in dosage strengths of 10 milligrams, 20 milligrams and 40 milligrams. The 80 milligrams dosage is not part of the recall. The company said “select batches” might contain glass particles, measuring less than one millimeter. Lot numbers and product details can be found at http://ranbaxyusa.com/images/a.pf
India-based Ranbaxy came under fire from FDA officials over conditions at two Indian plants in 2006 and 2008. This led to a January 2012 agreement with the Justice Department, which cited the company from manufacturing drugs for the American market at those facilities until they could meet U.S. standards. There were manufacturing deficiencies at multiple Ranbaxy factories and alleged doctoring of test results on some medicines. In mid 2008, U.S. regulators banned imports of 30 Ranbaxy medications and refused to approve any new products for sale until Ranbaxy agreed to make improvements, as well as agree to monitoring by a third party for a five year period. The U.S. Department of Justice demanded Ranbaxy turn over internal documents, alleging the company lied about ingredients and formulations of some medicines. The government also accused them of falsifying data used in drug applications.
Ranbaxy’s manufacturing deficiencies dating back to 2006, led to a lengthy investigation and sanctions by the FDA. Federal investigators found that Ranbaxy did not properly test the shelf life and other safety factors of its’ drugs and then lied about the results of more than two-dozen drugs.
Last December, Ranbaxy agreed to make changes to their manufacturing plants in both the U.S. and India and said they set aside $500 million to resolve any potential civil or criminal charges stemming from the investigation by the U.S. Department of Justice.
As the FDA discussions with Ranbaxy continued, it was apparent Ranbaxy would lose its chance at a revenue windfall when Lipitor’s generic U.S. patent expired last November 30. At that time it had brought in almost $8 billion a year in U.S. sales.
When patents expire, only one generic rival can compete with brand name Lipitor for the first six months. Ranbaxy had that right, although an authorized generic from Lipitor-maker, Pfizer Inc. and partner Watson Pharmaceuticals Inc., went on sale on December 1st. With competition so limited, the generic prices declined from brand-name drug’s price of about $115 a month, until several other generics entered the market six months later.
The FDA finally ended the suspense, deciding just before midnight on November 30th to let Ranbaxy sell generic Lipitor made at the company’s Ohm Laboratories factory in central New Jersey. It was unclear Friday whether the recalled Ranbaxy pills were made there or somewhere else.
Presently, Ranbaxy is operating under a settlement with the FDA, known as a consent decree, signed on December 20, 2011. It requires Ranbaxy to improve its manufacturing procedures, ensure the data on all of their products is accurate and undergo extra oversight and review by an independent third party for a five year period.
Patients who have filled a prescription can contact their pharmacy to inquire whether the generic was manufactured by Ranbaxy or from another generic drug maker and, if it came from Ranbaxy, whether it came from a recalled lot.
Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).