|Ranbaxy headquarters, Gurgoan, India |
Ranbaxy Laboratories Ltd. has recalled more than
40 lots of its generic version of the cholesterol-lowering drug Lipitor from the
US market after finding batches containing small glass particles.
The Wall Street Journal reports that Ranbaxy,
which is headquartered in India and is owned by Japan's Daiichi Sankyo Co., said
the voluntary action would cause a temporary supply disruption, but the company
expects to complete an investigation of the matter within two weeks and resume
The Food and Drug Administration 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 spokeswoman. "We're monitoring the
The FDA said it wasn't aware of any reports of
injuries or deaths tied to the recalled product.
The Journal said Pfizer has lost patent
protection of Lipitor and its sales declined 56% to $3.36bn for the first
nine months of 2012. Ranbaxy's generic Lipitor sales covered 44% of the US
market for the drug.
Ranbaxy said Friday it is conducting a
retail-level recall of certain lots of 90- and 500-pill bottles of atorvastatin,
in dosage strengths of 10 milligrams, 20 milligrams and 40 milligrams. The
80-milligram dosage isn't part of the recall.
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