FDA bans dozens of Ranbaxy-made generic drugs...

U.S. health officials have banned dozens of medications made by Ranbaxy Laboratories Ltd after the generic drugmaker failed to fix numerous problems with its manufacturing operations, including record-keeping and other procedural issues.

The U.S. Food and Drug Administration on Tuesday said it would block more than 30 generic drugs from entering the United States following ongoing records violations at Ranbaxy's Dewas and Paonta Sahib plants in India.

It also will not approve any new drugs made at the plants until the problems are resolved, the FDA said.

Representatives for Ranbaxy. which has agreed to a takeover by Japan's Daiichi Sankyo Co Ltd, could not be immediately reached for comment.

FDA officials said the violations concerned the manufacturing process and not the drugs themselves, urging patients not to stop taking any medications and to talk to their doctors.

A sampling of products made at the two plants showed no concerns, agency officials added.

"Ultimately, the deficiencies in the process have reached the level where we think an import alert is justified," Deborah Autor, director of the FDA's Office of Compliance at the Center for Drug Evaluation and Research, said.

The so-called "import action" affects numerous, widely-used medications including generic versions of Merck's cholesterol-lowering drug Zocor, also known as simvastatin, as well as several AIDS medications.

Other affected drugs include the antibiotic ciprofloxacin, diabetes therapy metformin, cholesterol medicine pravastatin, and the over-the-counter version of allergy drug loratadine.

Despite the ban, the FDA said that consumers should not be affected and that drug shortages were unlikely.