Johnson and Johnson’s CEO, Bill Weldon, is apologizing for the recent recall of over-the-counter (OTC) children’s medications.
In a letter posted on the J & J, By The Way Web site, and referring to the recent recalls of 40 OTC consumer products, Weldon says the recalls “are a disappoint to me and to the employees of the Johnson & Johnson Family of Companies. You can be confident that we will make whatever changes are needed at McNeil to fully restore the quality of its manufacturing.”
FDA inspectors found thick dust and grime covered drug making equipment and there was a hole in the ceiling. Duct tape was used around pipes and raw ingredients contained an unspecified bacteria, according to the FDA report dated April 30.
The findings led the a May 1 recall of 43 Tylenol brand children and infant products, including Concentrated Tylenol Infant Drops, Children’s Motrin, Children’s Zyrtec, Benadryl, and other over-the-counter products.
And in an unusual move, the FDA recommends parents choose generics or private label brands over the J & J subsidiary, McNeil’s Tylenol brand children’s and infant products.
Workers reply on the By The Way Web site how they have seen the quality degenerate at McNeil, a subsidiary purchased by J & J. Another person says they are disturbed by the mild language used in the recall. She says her son, age 3, had a reaction to Zyrtec Syrup in mid-April and experienced severe diarrhea with blood and mucus which landed him in the emergency room and undergoing a colonoscopy.
Philadelphia.com contains comments, also unsubstantiated, by people claiming to have worked there who note the company’s good manufacturing practices have disintegrated and the company has replaced managers with low paid workers.
There are still many unanswered questions about how this leading manufacturer of over-the-counter medications could be responsible for three major recalls over the last year.
The House Committee on Oversight and Government Reform is opening an investigation into the Johnson & Johnson subsidiary, McNeil, and its recall of 40 popular children’s pain and allergy medications. Darrell Issa, a Republican from California, and Edolphus Towns, Democrat of New York and the committee chair say they want to know if the FDA’s inspection procedures are adequate and whether McNeil failed to look into consumer complaints about contamination problems.
Investors Not Disappointed
Johnson and Johnson’s McNeil Consumer Healthcare division has not disappointed investors reports The Street. J & J stock fell 2.6%, less than the Dows 7% fall as investors seem to be taking the bad news in stride, including a report that the Department of Justice has charged and J & J subsidiaries (McNeil-Janssen Pharmaceuticals and Ortho-McNeil Pharmaceuticals) have agreed to pay $81 million for illegally promoting the epilepsy drug, Topamax.
The FDA has still not yet announced the type and source of the bacterial contamination and tiny particles found in Children’s Tylenol products. A poll taken by The Street finds that more than 70% of voters say they will continue to trust J & J products.
J & J has suspended production of its children cold product at its Fort Washington, Pennsylvania plant after some formulations were found to be super potent with active ingredients. The FDA Inspection report on the McNeil plant, issued April 30, failed to say how "off" the dose was, but overdoses of Tylenol, or generic acetaminophen, can cause liver failure.
In a press briefing May 4, FDA Commissioner, Margaret Hamburg said the recall is a large one involving more than 50 over-the-counter medications for infants and children. Deb Autor, of the FDA Center for Drug Evaluation and Research, said the firm failed to sufficiently investigate and correct problems found in its manufacturing plant.
In February, the FDA met with McNeil and J & J reps to discuss the manufacturing operations. Problems uncovered then led to the April inspection. The Fort Washington plant has been shut down indefinitely. The gram negative organism bacterial contamination has not been identified.
A further evaluation of the inspectors report and a final conclusion could lead to further regulatory action.
J & J had quality control problems at a McNeil plant in Puerto Rico that created a musty odor in Tylenol Arthritis Relief, Motrin, Benadryl and Rolaids. The odor was eventually found to have come from a flame retardant and pesticide was used on the wooden shipping pallets.
Expect a round of positive advertising to turn the public perception around reports Philadelphia.com. #