Under investigation from the Food and Drug Administration (FDA), McNeil Consumer Healthcare has implemented a widespread voluntary recall of many popular infant and children's medicines, effective April 30, 2010. Infant and Children's Tylenol®, Motrin®, Zyrtec®, and Benadryl® brands are all affected by the recall (click here for the complete listing).
The warning has been issued due to safety and quality concerns. Some of the products recalled may contain a higher concentration of active ingredient than specified on their labels, others contain inactive ingredients that may not meet testing requirements and still others may contain tiny particles. “While the potential for serious health problems is remote," stated Margaret A. Hamburg, M. D., FDA Commissioner of Food and Drugs, "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.”
In the meantime, parents and caregivers are cautioned against giving these medications to children. Adult versions of these products may not be substituted but there are many generic alternatives, intended for infants and children, that may be used.
If your child has already been exposed to medications included in the recall, the potential for serious medical problems is remote but a healthcare professional should be consulted if unexpected symptoms occur. Adverse reactions or quality problems experienced with the use of these products may also be reported to FDA's MedWatch Adverse Event Reporting program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Photo courtesy of Epitomized Thinking; photo by Sheila G.