After two reports of moldy or musty odors emanating from Lipitor ((atorvastatin calcium) 40 milligram tablet bottles, Pfizer has issued a recall of a further 38,000 bottles. Two weeks ago the company had recalled 190,000 bottles for the same reason. Lipitor is a cholesterol-lowering medication; it also stabilizes plaque and prevents strokes. Lipitor is a blockbuster with global sales of $12.4 billion in 2008, sales reached $5.57 billion during the first half of 2010.

Total recent Lipitor recalls have totaled over 330,000 bottles because of complaints of a musty smell. The company says the source of the problem comes from a third party manufacturer. It warns that additional recalls me be required because the production, transport and storage alterations may have occurred after some more batches of the product reached the market.

This year the number of recalls in the USA have been higher than usual. Johnson & Johnson has had to issue several recalls regarding some of its over-the-counter (OTC) medications, while GSK (GlaxoSmithKline) had to negotiate a $750 million payout when it pleaded guilty to poor manufacturing practice at its Puerto Rico factory.

Traces of TBA (2,4,6 tribromoanisole) were found in some sample bottles after an inspection. TBA is a wood preservative that is applied to the wooden pallets that were used to transport and store the Lipitor bottles. Earlier this month Johnson & Johnson recalled 127,728 bottles of Tylenol after reports the OTC painkiller had a weird, musty odor.

Pfizer assures customers that changes were put into place in August to address the source of the problem, including the use of plastic pallets to transport empty bottles, and that this latest Lipitor recall is of products produced, transported and stored before they went into effect.

The company explained in a communiqu?©:

Research indicates that a major source of TBA appears to be 2, 4, 6-tribromoanisole(TBP), a chemical used as a wood preservative. Although TBP often is applied to pallets used to transport and store a variety of products, Pfizer prohibits the utilization of TBP-treated wood in the shipment of its medicines.

The health risk caused by this musty odor is minimal, Pfizer assures.

The company's Puerto Rico plant was shipping empty bottles to a plant in Freiburg, Germany, where products would be placed into the bottles. Bottle production is now done elsewhere.

A company spokesperson said:

We have thoroughly evaluated the root cause, which is episodic exposure of the bottles to low levels of TBA as they are shipped or stored.

Pfizer added that there have been three complaints per million bottles.

Some experts voiced concern that the musty smell could put some patients off taking their medication.