Children’s Benedryl recall latest to hit J&J

By Dow Jones Newswires
Posted Nov. 22, 2010 at 4:57 p.m.

Johnson & Johnson has recalled about 4 million packages of children’s Benadryl allergy tablets and about 800,000 bottles of junior-strength Motrin, citing “insufficiencies” in developing the manufacturing process.

It was the latest in a series of product recalls in the last year that have hurt the reputation and financial results of J&J.

J&J said the latest recalls are being conducted at the wholesale and retail levels and that no action is required by shoppers or health-care providers. Consumers can continue to use the products, J&J said.

“There’s no safety issue, and consumers don’t have to take any action,” said Bonnie Jacobs, spokeswoman for J&J’s McNeil Consumer Healthcare unit, which makes the over-the-counter medicines. “There’s no indication the products don’t meet quality standards, and it’s not being undertaken on the basis of adverse events.”

Jacobs said McNeil had conducted a review as part of the plan it had submitted to the Food and Drug Administration this year to fix the quality problems cited in prior recalls. The review “revealed insufficiencies in the development of the manufacturing process,” according to a notice on the Benadryl Web site.

Jacobs declined to be more specific about the nature of the latest problem, other than to say the manufacturing process in question wasn’t developed as thoroughly as it should have been and “there’s nothing wrong with the products.” She declined to say what the financial effect of this recall might be.

The affected products are: Children’s Benadryl Allergy Fastmelt Tablets, in cherry and grape flavors,  distributed in the U.S., Canada, Belize, Barbados, Puerto Rico, St. Martin and St. Thomas; and Junior Strength Motrin Caplets, 24-count, distributed in the U.S. Get more information on the recall.

The notice on the McNeil site is dated Nov. 15, but J&J didn’t issue a press release on the matter, as it has done with several of its recalls in the last year. Jacobs noted that it is not a consumer-level recall,and that J&J did post information about the recall on the product Web sites.

J&J, of New Brunswick, N.J., has previously recalled Tylenol and other over-the-counter brands due to quality problems, such as musty odors or floating particles in liquid solutions. The company shut down a manufacturing plant in Fort Washington, Pa., for an upgrade aimed at fixing the quality problems.

Various governmental entities are investigating J&J over its handling of the recalls, including a criminal probe by the  Justice Department.

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