Pfizer Recalling Lipitor Due to "Musty Odor"

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Pfizer initiated a recall of Lipitor (atorvastatin) in August due to complaints of an uncharacteristic “musty odor.” The “musty odor” was due to a chemical contamination identified as 2,4,6 tribromoanisole.

Pfizer initiated the recall of seven lots of the branded drug distributed in the U.S. and Canada in August but is only now making it public.

The Food and Drug Administration (FDA) has been monitoring the recall. A total of 191,000 bottles of the cholesterol-lowering agent in 40-mg strength are included in the recall.

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Five of the recalled lots were distributed in the U.S. and two in Canada under the Lipitor brand. Three additional lots were sent to a Canadian producer of generic drugs. The lots included in the recall were 0855020, 0819020, 0842020, 0843020, 0854020. The date of expiration for these lots was 01/13.

The manufacturers listed in the recall are Pfizer Ireland Pharmaceuticals, Ringaskiddy, Co. Cork, Ireland;
Pfizer Manufacturing Deutschland Gmbh, Freiburg, Germany; and Rexam, Las Piedras Puerto Rico.

The FDA states the recall is ongoing.

2,4,6 tribromoanisole was the cause of the "musty odors" behind Johnson & Johnson's massive recall of Tylenol brand acetaminophen products that began in 2009, followed by additional recalls of other drugs that had prompted similar complaints.

Sources
FDA
Pfizer

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