Drug Maker Recalls More Than 40 Allergy, Cold Meds for Kids
Medicines involved in the voluntary action include Tylenol, Tylenol Plus, Motrin and Benadryl
SATURDAY, May 1, 2010 (HealthDay News) -- McNeil Consumer Healthcare on Friday recalled more than 40 of its liquid cold and allergy products for children because some of the medications may not meet federal quality standards.
The medicines involved in the voluntary recall include Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl. These medications have been sold in the United States and 11 other countries, the company said.
"This recall is not being undertaken on the basis of adverse medical events," McNeil said in a statement on its Web site. "However, as a precautionary measure, parents and caregivers should not administer these products to their children."
"Some products in the recall may have a higher concentration of active ingredient than specified while others may have inactive ingredients that don't meet testing requirements," the company explained. Others may contain particles, while still others may contain inactive ingredients that do not meet internal testing requirements.
McNeil worked with the U.S. Food and Drug Administration in reaching the decision to issue the 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," FDA Commissioner of Food and Drugs Dr. Margaret A. Hamburg said in a statement.
"While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more," Hamburg added.
According to the New York Times, an FDA spokeswoman said that violations found while inspecting McNeil's Fort Washington, Pa.-based plant led to the decision to recall the children's products. Earlier this year, the company recalled some of its products following reports of moldy smells among over-the-counter medicines made at a plant in Puerto Rico. The earlier recall involved certain lots of Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol, the Times reported.
For a complete listing of the recalled products, visit McNeil Consumer HealthCare.