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FDA - Systemic Lapses In Children's Tylenol Manufacturing

Posted by Jane Akre
Thursday, May 27, 2010 3:54 PM EST
Category: Protecting Your Family
Tags: FDA, Johnson & Johnson, Children' Tylenol, Sharfstein, Goggins, McNeil Healthcare

Colleen Goggins, Johnson & Johnson

Systemic Manufacturing Lapses At J & J


IMAGE SOURCE: Image of Colleen Goggins, chair J&J from House Oversight and Government Reform Committee

Legislators concluding a committee hearing Thursday into Johnson & Johnson’s (J & J) recall of children's liquid medications, say the Food and Drug Administration (FDA) needs mandatory recall capability to more quickly address lapses in drug manufacturing and safety.

Lawmakers from the House Committee on Oversight and Government Reform concluded what they heard from a company executive was “not reassuring” despite her insistence that no children have been harmed by the recalled medications.

So far no direct link has been established between an April 30 recall of 40 types of children’s medications, the largest recall of its type in the history of the FDA, and 775 reported adverse events, including a number of deaths, according to a congressional report released Tuesday.

The latest recall for J & J is the fourth in eight months and has lawmakers concluding there are systemic problems with the Johnson and Johnson, and its McNeil Healthcare subdivision.

Colleen A. Goggins, worldwide chairman of J & J’s Consumer Group was brought in to field questions for the company in place of CEO, William Weldon, who was absent due to back surgery.

She assured lawmakers that six key management personnel have been fired and replaced at the Fort Washington, Pennsylvania plant that manufactures the children’s medications and at a problematic plant in Puerto Rico that was producing J&J products with a foul odor last year.

“We’ve undertaken a broad assessment" of the plants," she said, promising to have a master plan in place by July 15.


On April 30, 40 brands of the popular children’s over-the-counter liquid pain and allergy medications were recalled after FDA inspectors found glaring problems at its Pennsylvania plant, including dirty conditions, inconsistent formulations, a bacterial contamination, and particulate matter in some brands.

Brands recalled include Children’s Tylenol, Motrin, Benadryl and Zyrtec – roughly 70% of liquid pain and allergy products sold over-the-counter (OTC) for children and infants.

Among the problems at the Pennsylvania plant was a bacterial contamination of B. cepacia, a bacteria that Rep. Dennis Kucinich (D-Ohio) noted had been positively identified in two children, one of whom died.

Goggins insists the company never let any contaminated medications enter the marketplace.

Credibility Problem

The FDA is launching a companywide investigation of Johnson & Johnson to determine how widespread manufacturing deficiencies are throughout the company.

Among them, a McNeil manufacturing plant in Puerto Rico that in November 2009 was found to be producing Tylenol products with a “musty or moldy” odor. Tylenol Arthritis Pain 100 count was recalled. The odor was later attributed to a fungicide that had been used on wooden pallets sourced in Latin America.

In earlier testimony, FDA Deputy Commissioner Joshua Sharfstein told the committee FDA inspectors have been checking McNeil facilities and took the unusual step of meeting with J & J management.

The FDA says 136 million bottles of medications had been recalled indicating a series of systemic quality problems at J & J and its McNeil consumer unit’s manufacturing facilities.

Chairman Edolphus Towns said Thursday, “It turns out there wasn’t just one recall. What we have heard about today is rolling recalls, a phantom recall, a plant shut down, and management firings. I was hoping that J&J would be completely forthcoming today, but I think there are still unanswered questions.”

The committee produced a documents subcontractors were suppposed to follow when removing Motrin from gas station shelves.


Recall Authority

The FDA is weighing whether civil or criminal charges could be filed against the company.

Rep. Jackie Speir (D-CA) called the 800-pound elephant in the room – the FDA’s inability to issue a recall when it deems necessary instead of waiting for the company to issue its own recall.

Towns concluded, “One thing we know now is that the FDA needs mandatory recall authority. They shouldn’t have to persuade a company to recall suspect products. I intend to introduce legislation to give FDA that authority. FDA should also have the power to order a halt in drug production.” #

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