CHICAGO – Johnson & Johnson (JNJ) is recalling certain infants' nonprescription cough and cold products because of the danger of overdose, the company said on Thursday.
Data show that when misused, the medicines can lead to overdose, especially in infants under 2 years old, the company said.
The company is recalling Concentrated Infants' Tylenol Drops Plus Cold, Concentrated Infants' Tylenol Drops Plus Cold & Cough, Pediacare Infant Drops Decongestant, Pediacare Infant Drops Decongestant & Cough, Pediacare Infant Dropper Decongestant, Pediacare Infant Dropper Long-Acting Cough, and Pediacare Infant Dropper Decongestant & Cough products from the U.S. market.
The drugs are made by J&J's McNeil Consumer Healthcare unit, which also makes Tylenol, Benadryl, Rolaids antacid, St. Joseph aspirin, Sudafed nasal decongestants and Motrin.
Cough and cold products for children aged 2 and over, and single-ingredient pain reliever/fever reducers expressly labeled for infants, are not included in the recall.
Questions have been raised for more than a year about the safety of the use of nonprescription cough and cold products in children and whether the benefits justify any potential risks, especially in children under 2 years of age.
Safety experts for the U.S. Food and Drug Administration have urged the agency to consider a ban on these medicines for children under the age of 6 years.
The issue is still under review at the FDA.
Many experts say there is little evidence that these medicines are effective in such young children and are calling for mandatory warning labels that say the medicines should not be used in children under 2 years of age.
Questions about the products should be directed to McNeil's Consumer Relationship Center at 1-877-895-3665 (English) or 1-888-466-8746 (Spanish).