October 11, 2007: Infants' Cough And Cold Product Recall
Several cough and cold products have been recalled; image here represents just one.
As stated in a recall on the Johnson & Johnson website, “When used as directed, these medicines are generally recognized as safe and effective. While most parents use these medicines appropriately and follow dosing directions, an assessment of available data on the use of pediatric cough and cold medicines has identified rare instances of misuse leading to overdose, particularly in infants under two years of age.”
McNeil Consumer Healthcare says this recall is in compliance with recent Food and Drug Association (FDA) urgings to make label changes to over-the-counter (OTC) cough and cold medicines, including adding “do not use” advisories for children under two years of age.
Do You Own These Products?
The following are cough and cold products listed in the recall:
- Concentrated Infants’ Tylenol® Drops Plus Cold
- Concentrated Infants’ Tylenol® Drops Plus Cold & Cough
- PediaCare® Infant Drops Decongestant (PSE)
- PediaCare® Infant Drops Decongestant & Cough (PSE)
- PediaCare® Infant Dropper Decongestant (PE)
- PediaCare® Infant Dropper Long-Acting Cough
- PediaCare® Infant Dropper Decongestant & Cough (PE)
Cough and cold products for children age two and over and single-ingredient pain reliever/fever reducers expressly labeled for infants are not included in this voluntary withdrawal and remain available for parents and caregivers.
Who to Contact
According to the release, consumers or retailers who have questions or concerns about the products described in this communication should contact McNeil’s Consumer Relationship Center at 1-877-895-3665 (English) or 1-888-466-8746 (Spanish) or visit www.tylenol.com
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