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/

New York Times: Glaxo to Pay $750M for Sale of Bad Products

Regulators say that GlaxoSmithKline, the British drug giant, knowingly sold tainted baby ointment, an ineffective antidepressant and contaminated drugs.

In an article written by Gardiner Harris and Duff Wilson which appeared in the New York Times-GlaxoSmithKline, the drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant.

The following are the highlights from the New York Times article:

• This settlement is the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion-dollar fines.

• Altogether, GlaxoSmithKline sold 20 drugs with questionable safety that were made at a huge plant in Puerto Rico that for years was rife with contamination.

• Cheryl D. Eckard, the company’s quality manager, asserted in her whistle-blower suit that she had warned Glaxo of the problems but the company fired her instead of addressing them.

• Among the drugs affected were Paxil, an antidepressant; Bactroban, an ointment; Avandia, a troubled diabetes drug; Coreg, a heart drug; and Tagamet, an acid reflex drug.

• No patients were known to have been sickened, although such cases would be difficult to trace.

This is the latest in a string of quality control issues at pharmaceutical manufacturers both domestically and abroad.

Most troubling is that the contamination's impact to consumers is difficult to trace. No one can be certain if bad product may have had a significant or even lethal impact on its consumer.

While the financial settlements to GSK and others is large, overiding these amounts is the cost to their brands in lost trust and consumer confidence.

It is critical that all members of the pharmaceutical supply chain utilize technologies to protect their products, inventories and ultimately the consumer from poor quality, adulteration, fraud and counterfeiting.

To read the entire New York Times article, visit: http://www.nytimes.com/2010/10/27/business/27drug.html?_r=1&th&emc=th

To learn more about pharmaceutical authentication solutions, visit: http://www.xstreamsystems.net/.

Tylenol Pain Caplets Recalled Due to Trace Chemical Which Causes Nausea and Vomiting

The Associated Press and other major media outlets are reporting that Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets due to consumer reports of a moldy smell that can cause nausea and sickness.

The FDA released a statement on their website that Johnson & Johnson is now recalling all product lots of the Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap. Johnson & Johnson had previously recalled five lots of the product last month after consumers complained of a musty, mildew-like odor that triggered nausea, stomach pan, vomiting and diarrhea.

Johnson & Johnson is saying that the odor results from trace amounts of a chemical called 2, 4, 6-tribromoanisole. That chemical is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials. To date, the side effects, which also include vomiting and diarrhea, have been "temporary and non-serious," although the health effects of the compound have not been studied.

The company will reintroduce Tylenol Arthritis Pain Caplets 100 count by January after moving production to a new facility.

For more information on the recall visit the Tylenol website: http://www.tylenol.com/.

This recall, based on onsite product contamination, energizes the need for material screening of products within the supply chain to protect consumers from fraud, adulteration, contamination and counterfeit products.

To learn more about onsite pharmaceutical material screening solutions, visit: www.xstreamsystems.net.