Johnson & Johnson admits recall lapses, FDA slammed for being "cozy"

"This episode was not a model for how I would like to see Johnson & Johnson companies approach problems with defective products," Weldon said.

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Joshua Sharfstein, the FDA's principal deputy commissioner, said the agency ought to have figured out the "phantom recall" and should have pressured Johnson & Johnson into making the recall public.

Sharfstein said the episode highlighted the need for Congress to give the agency that power.

Since last spring, Johnson & Johnson, once considered a standard-setter for safety, has recalled millions of batches of sub-standard OTC medications including Tylenol, Motrin and Benadryl.

It was also forced to shut down Fort Washington, Pennsylvania-based factory run by its subsidiary McNeil Consumer Health Care after a FDA probe found Johnson & Johnson implementing poor quality control measures at its plants. The probe found some of the Johnson & Johnson products could have more active ingredients than stated while others could contain tiny metallic particles. The probe also found some drugs containing bacteria.

The FDA, however, said it has not received any report linking any recalled product directly to any serious ailment or death.

Weldon said, Thursday, he accepted "full accountability" for the problems at the McNeil unit.

Johnson & Johnson has also come under fire for waiting a year before notifying the agency in September 2009 that a musty or moldy odor on bottles of Tylenol and other OTC medications made people complain of nausea and vomiting.

The smell eventually was traced to a chemical called tribromoanisole or TBA, a pesticide used to treat wooden shipping pallets.

"We should have determined the root cause in 2008," Weldon said.