J&J faults cleaning procedures in massive recalls

Boxes of Tylenol cold medication are seen in a pharmacy in Toronto January 31, 2008.

NEW YORK (Reuters) - Johnson & Johnson faulted lax cleaning procedures and other problems at a manufacturing plant behind massive recalls of medicines like Tylenol, and said it was recalling nearly 50 million more bottles and packages of consumer medicines.

The healthcare company's reputation has been tarnished by repeated recalls totaling nearly 200 million bottles in the last year and it could face criminal charges from the U.S. Department of Justice.

Johnson & Johnson is now recalling bottles and packages of various kinds of Tylenol, Benadryl, Rolaids and other consumer products, it said on Friday.

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.

While the company said it had identified a number of areas for improvement, on Friday it disclosed only the cleaning problem and a minor labeling irregularity.

The company investigation found insufficient equipment cleaning procedures and instances where people failed to adequately document cleaning at McNeil's Fort Washington, Pa. plant, the company said. 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.

The company said it recalled nearly 43 million bottles of Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol Upper Respiratory, Benadryl, Sudafed PE and Sinutab.

Additionally, nearly 4 million bottles, rolls and packages of Rolaids were recalled.

The company last month recalled all batches of Softchews Rolaids produced by an outside manufacturer after people found wood and metal bits in the tablets.

The recalls have kept popular products off drug store and supermarket shelves for months and hit the company's bottom line.

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 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.

The FDA declined to comment, citing its investigation into the J&J recalls.

J&J shares closed down 36 cents, or 0.5 percent, at $62.55 on the New York Stock Exchange.

(Reporting by Bill Berkrot and Lewis Krauskopf. Editing by Andre Grenon and Robert MacMillan)