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FDA Widens Tylenol Probe "Worst I've Seen" Says Expert

Posted by Jane Akre
Tuesday, May 18, 2010 12:12 PM EST
Category: Protecting Your Family
Tags: Tylenol, Children's Medications, Johnson & Johnson, McNeil Healthcare, FDA

Problems for J & J


IMAGE SOURCE: Reuters Web site

The Food and Drug Administration (FDA) plans to widen its probe beyond the deficiencies found at the Pennsylvania Johnson & Johnson manufacturing plant that was responsible for the recent recall of children’s Tylenol.

A May 6, FDA inspection report found glaring problems at the Fort Washington facility including active ingredient concentrations that were inconsistent and “superpotent” and tiny metal particles in some formulas.

David Leo, a Temple University professor of pharmaceutical manufacturing calls the list of 20 violations “shocking” and “pretty close to being the worst I’ve seen. It suggests that basically the FDA found an issue with almost every system at the plant,” he said in a CNN interview.

The most damning, according to Leo, was the charge that the plant "does not maintain adequate laboratory facilities for the testing and approval (or rejection) of components of drug products."

The report also found employees at the plant were not trained in best manufacturing practices, there were dusty and filthy conditions and a large hole in the ceiling.

Some drums of raw materials had a bacterial contamination identified as B. cepacia.

The manufacturing facility has been shut by J & J.

In announcing the recall earlier this month of 50 versions of children’s non-prescription drugs including Tylenol, Motrin and Benadryl, J & J declined to comment to CNN what other products it makes at the facility.

And in an unusual move, the FDA recommended parents choose generics or private label brands over the J & J subsidiary, McNeil’s Tylenol brand children’s and infant products.

The Apology

“I think we have to apologize” says Bill Weldon, Chief Executive of J & J. “We have to understand this is not the way we normally perform this is not what we expect of ourselves,” he says in a Fortune Magazine interview.

Meetings between J & J and the FDA go back to February, but the recall was announced in late April.

And in violation of FDA rules, 46 consumer complaints to J & J were not forwarded to the FDA.

The House Committee on Oversight and Government Reform has scheduled a hearing for May 27 on the recall and McNeil's failure to respond to consumer complaints.

Companywide Problems

The FDA is launching an investigation of Johnson & Johnson to determine how widespread manufacturing deficiencies are throughout the company, says the FDA on its Web site, though it will not comment on how many J & J facilities fall under the expanded probe.

In November, 2009, a McNeil manufacturing plant in Puerto Rico was found to be producing Tylenol products with a musty of moldy smell. Tylenol Arthritis Pain 100 count was recalled due to the odor and subsequent illnesses among users.

And McNeil said in an e-mail to CNN that it is “conducting a comprehensive quality assessment across its manufacturing operations and continues to cooperate with the FDA.”

The latest recall is the fourth in seven months.

Baby Products

As for the safety of other J & J products, the nonprofit Campaign for Safe Cosmetics finds in its testing that Johnson & Johnson Baby Shampoo and Baby Magic lotion tested positive for 1,4-dioxane, a foaming agent, or formaldehyde, which are listed by the Environmental Protection Agency as probably carcinogens.

They do not appear on the label, the group finds, as they are byproducts of the manufacturing process. J & J says its follows government standards. The European Union bans 1, 4-dioxane in personal care products.

Parents can select products with fewer ingredients and no synthetic fragrance or dyes or choose products from the Environmental Working Group’s safety database, Skin Deep. #

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