By JONATHAN D. ROCKOFF
Johnson & Johnson is recalling all lots of certain over-the-counter infant and children's products, including various formulations of Children's Tylenol, Motrin Infant Drops and Children's Zyrtec syrup.
The New Brunswick, N.J., company's McNeil Consumer Healthcare unit is withdrawing the products due to manufacturing problems, the Food and Drug Administration said in a news release. Some of the medicines may contain a higher concentration of its active ingredient than they should, while others may contain inactive ingredients at levels the company deems inappropriate or tiny particles, McNeil said in a news release.
The company said there haven't been any serious side effects reported, and both the company and the FDA said the potential for harm is remote. Still, the company and the agency said the products shouldn't be given to children as a "precautionary measure."
An FDA spokeswoman said all the recalled lots came from the Johnson & Johnson unit's manufacturing plant in Fort Washington, Pa. A routine FDA inspection at the plant turned up the manufacturing problems, which prompted the voluntary recall, the spokeswoman said.
FDA Commissioner Margaret Hamburg said in a release that the FDA has launched an investigation into the "products and facilities associated with this recall."
"We want to be certain that consumers discontinue using these products and that they know what to do if they have concerns about a specific product," said Ms. Hamburg. "While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality."
Source: www.wsj.com
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