McNeil Consumer Healthcare/Johnson & Johnson is expanding its Jan. 15, 2010, recall to include four lots of Benadryl and one lot of Tylenol, the company announced on Tuesday. The company said these products were “inadvertently omitted from the initial recall action,” which took effect because of consumer reports of a moldy, musty odor from the medication. As in previous recalls, McNeil said that the risk of serious adverse events is remote.
McNeil’s January 2010 recall affected several of its over-the-counter products, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin, and Tylenol. The company also recalled lots of Tylenol Arthritis Pain 100 count with EZ-Open Cap in December 2009 because of the same odor. After an investigation following the Jan. 15 recall, the unusual odor was attributed to the presence of a chemical called 2,4,6-tribromoanisole (TBA). McNeil concluded that the TBA came from a chemical used on the wooden pallets that stored and transported packaging materials for the medications.
Specifically, the five newly recalled lots include: four lots of Benadryl Allergy Ultratab tablets, 100 count, sold in the US; and one lot of Extra Strength Tylenol Rapid Release Gels, 50 count, sold in the US, Trinidad and Tobago, Bermuda, and Puerto Rico, according to Tuesday’s press release.
The company’s latest announcement comes in the wake of a Congressional hearing and investigation about its April 30, 2010, of more than 40 infants’ and children’s products. The US House Oversight and Government Reform Committee also uncovered what Chairman Edolphus Towns called a “phantom recall” in which it appears Johnson & Johnson hired contractors to systematically remove certain Motrin products from store shelves in late 2008. Towns asserted that J&J initiated a recall only after FDA was made aware of the company’s actions, and earlier this month asked the contractors to provide details of their activity in the situation.
The New York Times reported last week that the committee and J&J disagree about their interpretations of the events of the “phantom recall.” J&J says nothing was wrong with the way it removed the products from stores and that there was no safety risk in the products. By not issuing a recall, the company wanted to take the product out of stores “with as little disruption and consumer confusion as possible,” said a McNeil spokesperson quoted in the NYT article. NYT obtained a July 2009 email from an FDA official to a McNeil executive that said, “It seems that your company is doing a recall even though you are calling it a ‘retrieval.’ The agency’s position is that your company should do a voluntary recall of the product since it appears to be that you are already doing a recall of the product.”
In his closing statement at the May 27 hearing, Towns said he would introduce legislation that would give FDA mandatory recall authority and the power to halt drug production. Do you think FDA should have this authority? The the results of PharmTech’s poll on the topic, available here.