The Wall Street Journal reported yesterday that some of McNeil Consumer Healthcare’s recalled infants’ Tylenol contained as much as 24% more acetaminophen than it should have, according to a letter the company sent to physicians and poison-control personnel. McNeil’s letter stated that the samples containing the 24% increase did not reach the public, but that the company could not be sure “all the individual bottles were within specification or that 24% would have been the maximum,” according to WSJ. A physician interviewed in the article said that the increased amount of active ingredient did not pose a health risk to infants because liver damage from acetaminophen occurs after high concentrations of the drug over a long period of time, not with occasional use of it.
The physician’s reassurance could come as comforting news to parents who may have given the affected medications to their children. Or, these new details about the seeming lack of manufacturing controls could shake consumers’ confidence in McNeil even more. As previously reported in PharmTech’s ePT, McNeil, a division of Johnson & Johnson, voluntarily recalled more than 40 variations of infants’ and children’s over-the-counter medications on April 30. The products were recalled because some may contain a higher concentration of active ingredient than is specified, others may contain inactive ingredients that may not meet internal testing requirements, and others may contain particles, according to McNeil. The company said the recall was precautionary and that no adverse events had been reported. The April 30 recall was the third in the past year, following a January 2010 and December 2009 recall of Tylenol and other products that contained a moldy, musty odor.
On May 5, the House Committee on Oversight and Government Reform said that it would investigate McNeil’s most recent recall to clarify some of the details because of discrepencies in the information the committee received from McNeil and FDA. According to a committee press statement:
“FDA and McNeil Consumer Healthcare have given conflicting accounts of the circumstances surrounding the recall, including what prompted the recall and how serious the recall is. In addition, as this is the third recall of Tylenol products in less than a year, the lawmakers are questioning the adequacy of FDA’s inspection procedures and whether McNeil failed to investigate consumer complaints that could have identified the contamination problems.”
Last week, the committee announced that a hearing is set for May 27. In letters posted on the committee’s website, Chairman Edolphus “Ed” Towns (D-NY) invited William C. Weldon, chairman and CEO of Johnson & Johnson, and FDA Commissioner Margaret Hamburg to testify at the hearing. However, according to J&J’s blog, JNJBTW, Weldon had back surgery yesterday and will not be able to attend the hearing. The company will send Colleen Goggins, worldwide chairman of the consumer group to the hearing in Weldon’s place.