By Peter Loftus
Ranbaxy Laboratories Ltd. (500359.BY) recalled more than 32,000 bottles of its generic version of cholesterol-lowering drug Lipitor over a potential pill mix-up in August--nearly three months before a larger recall for the presence of small glass particles in some bottles.
The retail-level recall in August was triggered by a pharmacist's discovery of a 20-milligram tablet of atorvastatin--the generic name for Lipitor--inside a sealed bottle of 10-mg atorvastatin, according to details posted online this week by the U.S. Food and Drug Administration.
In an August letter to customers initiating the voluntary recall of one product lot, Ranbaxy said it couldn't rule out the possibility that the pill mix-up occurred at its facility.
The FDA has now designated the August recall as Class 2, which is reserved for situations when use of a drug may cause temporary or medically reversible health problems, or where the probability of serious adverse events is remote.
The lot recalled in August was Ranbaxy's 10-mg, 90-count tablets, with lot number 2407258 and an expiration date May 2014, according to the FDA.
Ranbaxy spokesmen couldn't immediately be reached Thursday.
The mixed-pill recall preceded a separate, larger Ranbaxy recall earlier in November of 41 lots of its generic atorvastatin, because some may have contained tiny glass particles resembling fine grains of sand. Neither Ranbaxy nor the FDA have said how many bottles in total were recalled in the latest action.
Ranbaxy, which holds more than 40% of the U.S. market for atorvastatin prescriptions, said in a press release Wednesday the probability of an adverse health event due to consumption of the tablets recalled for potential glass particles is unlikely, but can't be ruled out.
Ranbaxy said it hadn't received any reports of adverse events related to the more recent recall. The affected lot numbers in the more recent recall can be found here: http://ranbaxyusa.com/newsdisp281112.aspx.
The FDA said in a statement Thursday Ranbaxy has stopped manufacturing atorvastatin until it has investigated the cause of the glass particles and fixed the problem. The FDA said it doesn't anticipate a shortage because generic Lipitor is available from several manufacturers. But the agency is monitoring the situation and is working with other manufacturers to ensure adequate supply.
Ranbaxy was one of the first companies to begin selling generic Lipitor in the U.S. a year ago, after Pfizer Inc. (>> Pfizer Inc.) lost market exclusivity for the branded version of the drug. Pfizer's Lipitor was once the best-selling drug in the world, but sales have plummeted as it lost market share to multiple generic alternatives.
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