The maker of Lipitor, Pfizer Inc., has issued a recall alert for 191,000 bottles of cholesterol-lowering drug Lipitor (atorvastatin) after receiving reports of an unusual musty odor emanating from containers. Lipitor is a statin - a medication used for lowering blood cholesterol. The drug also stabilizes plaque and prevents strokes through anti-inflammatory and other mechanisms. Lipitor sales reached US$12.4 billion in 2008, the best selling medication blockbuster worldwide.

Pfizer informs that complaints regarding the musty smell started coming in in July this year. It started the recall in August, but did not make it public until just now.

In all cases the strange smell appeared to have come from the same batch of bottles. According to Rick Chambers, a Pfizer spokesperson, that batch was not manufactured by Pfizer, but by a third party. The spokesperson did not reveal the name of the third party manufacturer.

Pfizer said it is working hard with the manufacturer to find out what caused the strange smell.

191,000 bottles are affected. They each contain 90 Lipitor tablets of 40mg. Five of the lots were sold in the USA, and two in Canada. According to the FDA, the five USA lot numbers are: 0855020, 0819020, 0842020, 0843020, and 0854020. Expiration date January 2013.

Pfizer says it has received three complaints about the smell, one of which also filed an adverse event (undesirable side effect) report.

In an interview with the TV news channel CNN, Rick Chambers said:

"We don't anticipate a product shortage resulting from the recall.

Some media sources have speculated that the problem may have originated from pesticide-treated pallets. In 2009 there was a massive recall of Tylenol following reports of a musty smell. In fact, the Tylenol odor problem eventually led to an FDA criminal investigation and a shake-up of the management of Johnson and Johnson.

This is not the first time in 2010 that Pfizer has had problems with a third party manufacturer. Debris was found floating in IV medication manufactured by Claris Lifesciences, which led to some recalls.