17 June 2010

J&J Expands January Recall to Add Benadryl, Tylenol

Bloomberg Business Week

Johnson & Johnson, under congressional investigation for a recall of children’s drugs, said it is expanding a separate January withdrawal of over-the- counter medicines to include lots that were “inadvertently omitted from the initial recall.”

The drugmaker’s McNeil Consumer Healthcare unit is recalling five product lots of Benadryl and Extra Strength Tylenol in addition to those announced on Jan. 15, New Brunswick, New Jersey-based J&J said today in a statement.

J&J is being investigated by the U.S. House Oversight and Government Reform Committee after pulling 40 types of children’s medicines on April 30. The January recall, of 500 lots of drugs including Rolaids, Motrin and some forms of Tylenol, was an expansion of a recall of Tylenol Arthritis Pain caplets announced in November 2009.

“This latest recall is further evidence that there are wide-ranging problems at Johnson & Johnson,” Representative Edolphus Towns, a New York Democrat and chairman of the oversight committee, said today in an e-mail. “I am troubled by what we have learned so far in our investigation and this latest development adds to my concern.”

Today’s recall involves four lots of Benadryl Allergy Ultratab Tablets, 100 count, sold in the U.S., and one lot of Extra Strength Tylenol Rapid Release Gels, 50 count, sold in the U.S., Trinidad and Tobago, Bermuda and Puerto Rico, J&J said in the statement.

J&J shares rose 72 cents, or 1.2 percent, to $59.14 at 4:15 p.m. in New York Stock Exchange composite trading. They have dropped 8.4 percent since Jan. 15.

Consumer Complaints

The January recall was the result of consumer complaints of a musty or moldy odor that has been linked to trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, found on storage pallets. The company received reports of nausea, vomiting and diarrhea after use.

The U.S. Food and Drug Administration sent a warning letter to J&J at the time, saying the drugmaker waited more than a year to notify regulators after getting complaints that tainted bottles of Tylenol sickened customers.

The medicine involved in that recall was made in J&J’s Las Piedras, Puerto Rico, manufacturing facility. The children’s medicines pulled this year were made in Fort Washington, Pennsylvania. The FDA is investigating all McNeil operations, and is closely monitoring J&J’s plan to correct its manufacturing lapses, Joshua Sharfstein, the agency’s principal deputy commissioner, said in May. The company may face seizures and criminal penalties, Sharfstein said.

Bonnie Jacobs, a spokeswoman for J&J, said the company had no further comment beyond its statement today.

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