UPDATE 2-U.S. senator probes J&J consumer drug recall

Tue May 25, 2010 2:34pm EDT

* Senate health chairman asks FDA for details on recall

* House committee to hold hearing Thursday

* J&J CEO, FDA commissioner not testifying

* Shares down 1.7 percent (Adds analyst comment, details of Harkin letter, other background, updates shares)

By Susan Heavey

WASHINGTON, May 25 (Reuters) - A U.S. senator is seeking more information about Johnson & Johnson's (JNJ.N) widespread recall of over-the-counter children's medicines, expanding on Congress' investigation of the company's actions.

The letter from Sen. Tom Harkin, chairman of the U.S. Senate's health committee, comes ahead of a Thursday U.S. House of Representatives hearing likely to renew attention on J&J.

Also on Tuesday, U.S. health regulators warned J&J over manufacturing lapses at its Ethicon unit's Advanced Sterilization Products division. [ID:nN25126916]

While Wall Street has so far shrugged off the recall, the hearing could trigger investor unease and consumer concerns over what is the fourth recall for J&J since September 2009. [ID:nN04125643]. The recall affects Children's Tylenol pain relievers and dozens of other liquid, nonprescription drugs.

FDA sought the J&J recall after agency inspectors uncovered contaminated ingredients at the company's Fort Washington, Pennsylvania, facility, although no finished products were found to be tainted. Inspectors also spotted grimy equipment, ceiling holes and other lapses at the plant.

Manufacturing of the liquid medicines has been suspended until the company fixes all the problems, and FDA officials have urged parents to give their children generic alternatives in the meantime.

In a letter to the U.S. Food and Drug Administration sent late on Monday, Harkin asked the agency's commissioner for more information on the nationwide recall.

A separate Senate hearing is not currently planned, Harkin's spokeswoman, Bergen Kenny, told Reuters on Tuesday.

In his letter, Harkin sought details on the company's actions, including whether it followed proper controls at the Fort Washington plant and issues concerning its ingredients supplier. He also said he wanted to ensure that the FDA has enough power to prevent and respond to drug contamination.

"I am especially concerned because so many of the drugs at issue in this recall were intended for infants and children," Harkin wrote FDA Commissioner Margaret Hamburg.

Representatives for the FDA and J&J had no immediate comment on Harkin's letter.

The recall will shave J&J's sales by $300 million this year, JP Morgan analyst Michael Weinstein said on Tuesday in a research note. Weinstein projects 2010 sales of nearly $62.3 billion for J&J.

Weinstein expects the recall will hurt J&J earnings by 3 cents per share this year, "but the impact could be greater if remediation costs are higher than expected."

Thursday's House Oversight and Government Reform Committee hearing aims to shed light on the recall, which began April 30 and also targets pain medicine Motrin as well as allergy drugs Benadryl and Zyrtec.

Colleen Goggins, Johnson & Johnson's worldwide chairman of the consumer group, and Josh Sharfstein, FDA's deputy commissioner, are expected to testify.

J&J Chief Executive Officer William Weldon and the FDA's Hamburg were invited to speak, but J&J has said Weldon is recovering from back surgery. Hamburg will be attending an Institute of Medicine meeting in Moscow, according to the FDA.

Shares of J&J were down 1.7 percent at $59.54 in afternoon trading the New York Stock Exchange. (Reporting by Susan Heavey; Adding reporting by Lewis Krauskopf in New York; Editing by Steve Orlofsky and Matthew Lewis)