Johnson & Johnson and its McNeil Consumer Healthcare unit have been all over the news lately for all the wrong reasons. Another recall was issued last week, as was news of a class-action lawsuit in the works against the company. The timeline below summarizes the recent events surrounding J&J/McNeil’s recalls and news.
Late 2008: The so-called “phantom recall” took place, in which J&J allegedly hired contractors to pose as customers and buy a certain type of adult Motrin in order to remove the product from store shelves. The House Committee on Oversight and Government Reform is currently investigating J&J’s actions in regards to the removal of the product from stores.
November 2009: McNeil recalled five lots of Tylenol Arthritis Pain Caplet 100 count bottles because of an unusual smell or taste. Nausea and related symptoms were reported by consumers.
December 2009: McNeil expanded the November recall to include all lots of Tylenol Arthritis Pain 100 count because of the unusual, moldy odor.
Jan. 15, 2010: McNeil recalled certain products, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin, and Tylenol, because of the same musty, moldy smell identified in the November and December recall. The company determined that the odor was caused by the presence of a chemical called 2,4,6-tribromoanisole (TBA), which originated from the breakdown of a chemical used on the wooden pallets that stored and transported packaging materials for the medications. According to the company’s press release, the health effects of TBA have not been well studied, but no serious adverse events have been reported in the medical literature. McNeil said it would stop shipment of products that came in contact with packaging materials stored on the pallets and would also require suppliers to stop using the pallets.
April 30, 2010: McNeil announced that more than 40 types of children’s and infants’ products were voluntarily recalled because the products may not have met quality standards. McNeil advised that the medications not be given to children and infants, as a precautionary measure. Quality issues included the possibility of the medication containing too much of the active ingredient, containing substandard inactive ingredients, or containing tiny particles. The recall included more than 135 million bottles of children’s medication.
May 5: 2010: The House Committee on Oversight and Government Reform announced an investigation into McNeil’s April 30 recall.
May 6, 2010: McNeil closed its Fort Washington, Pennsylvania, facility in connection with the April 30 recall.
May 14, 2010: The Committee announced a hearing scheduled for May 27 to examine the circumstances of the April 30 recall.
May 25, 2010: JNJBTW.com, J&J’s blog, outlined an action plan that was developed with the help of a consultant designed to improve quality and manufacturing conditions at McNeil Consumer Healthcare. The announcement of the outline stated that a detailed version of the plan will be submitted to FDA by July 15.
May 27, 2010: The House Committee on Oversight and Government Reform held a hearing on the April 30 recall. Joshua Sharfstein, FDA’s principal deputy commissioner, testified on behalf of FDA. Colleen Goggins, worldwide chairman of Johnson & Johnson’s Consumer Group testified in place of CEO Bill Weldon, who was unable to attend because he was recovering from back surgery.
Documents produced at the hearing revealed what Committee Chairman Edolphus Towns dubbed a “phantom recall,” in which it appeared McNeil hired contractors to buy certain adult Motrin products. Towns later accused McNeil of initiating a formal recall only after FDA “discovered this covert activity” in a June 3, 2010, press release.
May 28, 2010: Blacksmith Brands, a provider of over-the-counter drug and healthcare products, voluntarily recalled four types of pediatric medications that were manufactured at the Johnson & Johnson/McNeil Consumer Healthcare plant at Fort Washington, Pennsylvania.
June 2, 2010: Towns requested information from J&J about its “phantom recall” of Motrin in 2008. Also, Towns requested information from Blacksmith Brands about its May 28 recall of products manufactured by J&J.
June 3, 2010: Towns requested information from the contractor allegedly hired by J&J in the so-called “phantom recall.”
June 15, 2010: McNeil expanded its Jan. 15, 2010, recall to include five more lots of Benadryl and Tylenol that were “inadvertently omitted from the initial recall action,” according to a company release. The additional lots were recalled for the same unusual odor that caused the January recall.
June 22, 2010: CEO Bill Weldon was asked by the Committee to testify at a second hearing about the company’s recalls. A date was not set for the second hearing.
July 8, 2010: McNeil issued another recall related to the moldy, musty odor of the Jan. 15 recall. Twenty-one lots of certain Benadryl, Children’s Tylenol Meltaways, Motrin, and Tylenol were recalled as a precautionary measure. McNeil says that an ongoing internal review showed that these products could have come in contact with the pallets that contained TBA, and therefore could have the foul odor.
Also, five complaints filed in the U.S. District Court for Northern Illinois against McNeil are seeking class-action status. Consumers accused McNeil of fraud and racketeering for not recalling all of its children’s products and for not adequately reimbursing consumers for their out-of-pocket expenses.
July 15, 2010: J&J intends to share its detailed action plan for improving quality with FDA.