Johnson & Johnson on the Hot Seat for "Phantom" Recall of Motrin Tablets in 2008

Food and Drug Administration officials as well as business scholars agree that Johnson & Johnson failed in handling current recall crises. Specifically, at the end of 2009, Johnson & Johnson recalled some batches of Tylenol Arthritis Pain Relief caplets after receiving complaints from consumers of "moldy-smelling" bottles. Just a short time after, Johnson & Johnson expanded the recall to include Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin, and other Tylenol products. However, according to a Food and Drug Administration inspection, Johnson & Johnson’s behavior in response to the increasing number of consumer complaints was anything but swift. In fact, the recall occurred 20 months after the McNeil unit of Johnson & Johnson began receiving complaints. The FDA also sent Johnson & Johnson a warning letter stating that the company failed to conduct a timely, comprehensive investigation, did not identify the source of the problem and did not alert authorities in a prompt fashion–increasing the chance that more consumers would become ill from the tainted products.

Johnson & Johnson then issued a second recall of children’s liquid Tylenol, Motrin, Zyrtec, and Benadryl at the beginning of May due to FDA concerns that some of the products contained a higher concentration of an active ingredient than is specified on the packaging, and others contained inactive ingredients that did not meet internal testing requirements. While the company maintained that the chances of injury to children or infants were “remote”, the product issues were discovered after an April 19 FDA inspection of a McNeil plant in Fort Washington, PA uncovered “manufacturing deficiencies” including “small metallic particles” in some of the children’s products.

Now, Congressional Democrats are investigating an alleged “phantom recall” in which Johnson & Johnson attempted to hire a contractor to buy up defective Motrin painkillers distributed in 2008. The company’s handling of the defective Motrin tablets came to light during a Congressional hearing to investigate Johnson & Johnson’s continuous quality control issues. According to a May 28, 2009 letter obtained by the Associated Press, a House Committee chairman asked J & J’s CEO to turn over the information relating to the “phantom” recall. The resulting memo handed over to the congressional investigators was entitled “Motrin Purchase Project” and instructed that the hired contractor should simply act like a regular customer when making the purchases of the defective Motrin tablets. Furthermore, no mention of a recall should ever occur during the process.

The FDA recently announced that they are considering bringing criminal charges against Johnson & Johnson as a result of its poor handling of manufacturing problems. In the past, J & J maintained a “sterling” reputation for safety, particularly during the 1980s when it quickly pulled bottles of Tylenol tainted with Cyanide from store shelves.