FDA Investigating Drug Manufacturing At J&J's McNeil Unit

The U.S. Food and Drug Administration said Monday it is conducting a company-wide investigation of the Johnson & Johnson (JNJ) unit that makes Tylenol as part of a probe into the recent recall of more than 40 infant and children's products.

On April 30, J & J's McNeil Consumer Healthcare unit recalled several liquid formulations of infant and children's Tylenol, Motrin, Zyrtec and Benadryl products because of manufacturing problems. The company said some of the medicines had higher concentrations of active ingredient than specified, and some products may contain tiny metallic particles left as a residue from the manufacturing process.

The FDA has said raw material that was contaminated with bacteria was used to make "several lots" of infant's and children's Tylenol, although testing hasn't found any contamination of finished products.

In a statement posted on its website Monday, the FDA said it has received a large number of inquiries from consumers about how the manufacturing deficiencies found at McNeil may have impacted the quality and safety of the infant's and children's liquid products.

The FDA said it is currently reviewing complaints received by the agency, "to determine the significance of any adverse events reported and any connection to the use of the recalled products."

The FDA also said it is also conducting "a company-wide investigation of McNeil Consumer Healthcare's drug manufacturing practices to determine whether similar problems exist throughout the company and what additional steps the agency must take to ensure that these problems do not recur."

On May 27, the House Committee on Oversight and Government Reform plans to hold a hearing about the recall. The panel is looking into J & J's response to consumer complaints about the products as well as FDA's actions.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]