WebMD Medical News
Daniel J. DeNoon
Louise Chang, MD
Nov. 30, 2012 -- After recalling 41 lots of its generic Lipitor -- atorvastatin -- the FDA says Ranbaxy Inc. will stop making the drug "until it has thoroughly investigated" how glass particles got into the medication.
Although Ranbaxy supplied more than 40% of the generic cholesterol-lowering drug sold in the U.S., the FDA says it does not expect a shortage. Five other firms make generic Lipitor: Sandoz, Teva, Apotex, Mylan, and Dr. Reddy's.
The FDA says the tiny glass particles contaminating Ranbaxy's atorvastatin have only "a remote possibility" of causing harm. Ranbaxy says the particles, about the size of a grain of sand, might cause "physical irritation."
Ranbaxy makes atorvastatin, and puts it into pill form at its U.S. facilities. The active ingredient, however, comes from India. Ranbaxy's preliminary investigation suggests that this active ingredient was contaminated with the glass particles, according to FDA public information officer Sarah Clark-Lynn.
To date, there have been no reports of harm linked to Ranbaxy generic Lipitor.
It's not the first sign of trouble for Ranbaxy, the huge Indian pharmaceutical company owned by Japan's Daiichi Sankyo. Last January, the company signed an FDA-requested consent decree closing plants in India and the U.S. until it made "fundamental changes." None of those plants made the recently recalled generic Lipitor products.
The company admitted to several serious charges, including submitting false data to the FDA, failing to prevent contamination of sterile drugs, failing to prevent penicillin contamination of non-penicillin drugs, and inadequate testing of drugs to ensure they kept their potency until their expiration date.
The U.S. Justice Department said the action was "unprecedented in its scope."
The recalled atorvastatin comes as a white tablet packaged in plastic bottles. The 10-mg tablets bear the imprint "RX12," the 20-mg tablets bear the imprint ''RX828," and the 40-mg tablets bear the imprint "RX829." No 80-mg tablets are included in the recall.
Here's the list of the recalled atorvastatin products:
SOURCES:News release, FDA.FDA web site.Department of Justice web site.Ranbaxy web site.
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