Tuesday, November 2, 2010

Pharmalot: 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.

Ed Silverman in Pharmalot is blogging on another Pfizer Lipitor recall due to the product containing a musty, unpleasant odor.

According to Mr. Silverman:

• The drugmaker already recalled 191,000 bottles of Lipitor - but only the 40mg dose - after receiving consumer reports last July. Once again, the problem is blamed on packaging supplied by another company.

• “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.

• 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.

Pharmaceutical companies need to protect their brand and the consumer by deploying quality assurance testing of their product, post-production within the supply chain.

Not considered in Mr. Silverman's cost calculations are the cost of managing and returning the recalled product which easily doubles the actual retail cost of the product.

Once mighty brands are losing consumer confidence due to quality control problems that could and should be easily resolved.

Like the issue with J&J this contamination occurred because of issues with a chemical used in the pallets used to store and ship the product. Many things can impact the quality and efficacy of the drug within the supply chain.

To read the entire Pharmalot post, visit: http://www.pharmalot.com/

To learn more about pharmaceutical supply chain authentication technologies, visit: http://www.xstreamsystems.net/

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