Not due to adverse events; includes some Tylenol, Motrin, Zyrtec, and Benadryl products
MONDAY, May 3 (HealthDay News) -- McNeil Consumer Healthcare and the U.S. Food and Drug Administration have alerted health care professionals of the voluntary recall of various over-the-counter liquid products for children and infants, including Tylenol, Motrin, Zyrtec and Benadryl products, as some of them may not meet quality standards.
According to the FDA, the recall was not issued because of reported adverse events. However, while the potential for serious adverse events is small, the agency recommends that, as a precautionary measure, these products not be administered to children. Some of the products may contain a higher concentration of active ingredient than specified, inactive ingredients that may not meet internal testing requirements, or tiny particles.
The recalled products were manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago, and Kuwait. The FDA recommends that health care professionals and consumers report any adverse reactions to the FDA's MedWatch Adverse Event Reporting program.
"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," FDA Commissioner of Food and Drugs, Margaret A. Hamburg, M.D., said in a statement.