Wednesday, May 26, 2010

WSJ: J&J Details Recall Troubles

In the May 18 edition of the Wall Street Journal, Jonathon Rockoff writes about new details emerging from the problems with Johnson and Johnson’s production and recall of certain children's medicines. These details are coming forward as the company faces growing scrutiny in Washington, D.C.

Many of the details were obtained via a letter, dated May 1st from Johnson and Johnson to doctors and poison control officials.

Here are some of the highlights from the article:

· Some samples of recalled infants' Tylenol were tested to contain as much as 24% more active ingredient than shown on the label, according to a letter that J&J's McNeil Consumer Healthcare unit sent to doctors and poison-control officials that was reviewed by The Wall Street Journal.

· The company said the suspect medicines hadn't reached the marketplace, and its testing of other batches that had been released to the market didn't find any problems. "But we cannot confirm that all the individual bottles were within specification or that 24% would have been the maximum," according to the letter, which didn't indicate when or how the testing was done.

· The letter was dated May 1, the day after J&J recalled certain children's and infant's Benadryl, Motrin, Tylenol and Zyrtec cold and pain medicines after discovering unspecified manufacturing problems. The company said at the time that the medicines could contain higher concentrations of medicine than they should, among other potential issues, but didn't specify an amount.

· The J&J unit inadvertently neglected to include one version of Children's Zyrtec in the recall for five days, according to an email sent to the company's over-the-counter sales force. It told its sales force on May 5 that the 1 milligram grape version of children's Zyrtec "was inadvertently not included" in the recall.

· A spokeswoman for J&J's McNeil unit said the company sent the letter about infant Tylenol to health-care professionals in connection with the recall, and its "health assessment" indicates the chance that the recalled medicines will cause harm is remote.

· In conjunction with the April 30 recall, J&J's McNeil unit shut down the Fort Washington, Penn., plant that made the recalled products until it could fix the manufacturing issues and assure quality production. The company said that in addition to overly high concentrations of ingredients, the recalled liquid products may contain inappropriate levels of inactive ingredients or tiny metallic particles left as a residue from the manufacturing process.

· A Food and Drug Administration inspection of the plant had also found bacteria in raw materials set aside for use to make several lots of Tylenol.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.

To read the entire Wall Street Journal article, visit:

To learn more about supply chain security and verification solutions, visit:

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