Hold Your Nose: Pfizer Recalls More Smelly Lipitor

For the second time in three months, Pfizer is recalling thousands of bottles of its Lipitor cholesterol pill after smelling a musty odor. The drugmaker already recalled 191,000 bottles of Lipitor - but only the 40mg dose - after receiving consumer reports last July (look here). Once again, the problem is blamed on packaging supplied by another company ( read here).

"The company has identified the source of the problem - the bottle manufacturer’s plant in Puerto Rico, which had shipped empty bottles to the Pfizer plant in Freiburg, Germany for use in packaging Pfizer products," according to a Pfizer statement. The drugmaker adds that the risk of health consequences to patients "appears to be minimal, and steps are being taken to preserve product quality and patient trust," although still more recalls may occur.

Musty odors are a growing problem for pharma. The recall scandal enveloping J&J’s McNeil Consumer Healthcare unit came to light after the FDA earlier this year released a warning letter that the health care giant failed to take sufficient action in response to batches of Tylenol Arthritis Relief Caplets that had a musty smell (see here).

In fact, the same chemical contamination that plagued J&J has shown up in the Pfizer bottles - 2,4,6-Tribromoanisole (read this). In explaining the problem, a Pfizer statement notes that the chemical is used as a wood preservative, which is often is applied to pallets for transporting and storing products, although the drugmaker insists such wood is not be used in shipping its meds. And

In any event, this is getting costly for Pfizer. Assuming these are the same 90-count bottles that were recalled last time and that these sell for at least $1.50 each, or roughly $135 a bottle, that amounts to $5.13 million at retail, since the pricing comes from PharmacyChecker.com. Add that to the $25.7 million from the last recall and the total retail value is now north of $30 million. Again, that’s retail, not what Pfizer puts in its register, but this gives you some sense of the magnitude. And as we noted before, the lost dollars could have been used to hire a few scientists. As for customers, a spokseman says those who object to the stink can have their bottle replaced at their pharmacy at no charge.

4 Comments

The bottles being made in Puerto Rico may allow the package to read Made in USA or so .. ? This is bizarre .. I thought that Lipitor was made in Ireland or is that the financial address for Pfizer avoiding US taxes?

For context: a plastic bottle of windshield washer liquid is blown and labeled on the same filling line. The thing has a smell to it .. apart from the fact the stuff don't save lives.

Oct 29, 2010 - 2:41pm

Eddie.....the bottles are made in PR....the product is pkg'ed in Germany. The product itself may be made in Ireland...

At least the 10 conflicts each Guideline authors and publicity firms are based in the U.S.

How much does Pfizer save having 3 production plants? The cash price retail for 30 pills is $165 [Rite Aid] so is there a need to save pennies on manufacturing?

Fabreeze the stuff is you'd like.

Oct 29, 2010 - 5:21pm

Eddie, for a product like Lipitor it is standard to have at least two manufacturing plants online, with the second plant to serve as a backup in case of problems at one of the plants. Given Lipitor's market size, it would not surprise me to have a second backup plant.