FDA Investigating Drug Manufacturing At J&J's McNeil Unit
May 17 2010 - 3:15PM
Dow Jones News
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;
jennifer.corbett@dowjones.com
Johnson and Johnson (NYSE:JNJ)
Historical Stock Chart
From Dec 2024 to Jan 2025
Johnson and Johnson (NYSE:JNJ)
Historical Stock Chart
From Jan 2024 to Jan 2025
