J&J Announces another Tylenol Recall

Jan. 18, 2011
Citing lax cleaning procedures and other problems at one of its manufacturing plants, Johnson & Johnson announced it is recalling 50 million bottles and packages of various kinds of Tylenol, Benadryl, Rolaids and other consumer products. According to Reuters, this follows a year in which J&J recalled nearly 200 million bottles. This latest announcement was enough for the U.S. Department of Justice to consider criminal charges.

J&J said the new recall followed a review of records dating back to 2007 of products made by its McNeil consumer healthcare unit, which produces most of the recalled medicines sold in the United States. MH&L reported on the last recall in October, and identified wood pallets as a possible source of contamination.

While J&J said it identified a number of areas for improvement, as of January 14th it disclosed only the cleaning problem and a minor labeling irregularity.

According to the Reuters report, the company investigation found insufficient equipment cleaning procedures and instances where people failed to adequately document cleaning at McNeil's Fort Washington, Pa. plant. J&J suspended production there last April to address quality control lapses.

McNeil also found one product with a label that did not include all the information required by regulators, J&J said.

The latest recall involved products affected by those issues, the company said, adding that it was "very unlikely" that this harmed product quality.Last month J&J recalled all batches of Softchews Rolaids produced by an outside manufacturer after people found wood and metal bits in the tablets.

As a result of these recalls, U.S. sales of J&J consumer brands plunged 25 percent in the third quarter. It has begun to sell some of its brands, such as St Joseph's aspirin, the subject of an earlier recall.

McNeil is conducting assessments at other manufacturing sites and will take whatever steps are needed, which could lead to more product recalls, J&J said.

Kurt Bardella, spokesman for Representative Darrell Issa, chairman of the House Committee on Oversight and Government reform, said Issa is seeking ways to ensure the U.S. Food and Drug Administration can "better avoid a situation where a plant like the one in Fort Washington reaches this level of failure and uncertainty."

Too many departments and agencies have jurisdiction over food safety, creating "unnecessary bureaucratic overlap and confusion," Bardella added.