The Food and Drug Administration has announced recalls of three types of over-the-counter medications by McNeil Consumer Healthcare.
Consumers may continue to take previously purchased products, and no action is required by health care providers.
Three Tylenol Cold Multi-Symptom liquid products sold in the United States (Daytime 8-ounce Citrus Burst liquid, Severe 8-ounce Cool Burst Liquid, and Nighttime 8-ounce Cool Burst Liquid) were recalled Nov. 24. No adverse events were reported, but the product labeling needs to be updated to more prominently note the small (less than 1%) presence of alcohol from flavoring agents as an inactive ingredient. This ingredient had been listed on the package but not on the front of the medicine bottle. Tylenol’s maker, McNeil Consumer Healthcare, began the recall after an internal company review identified this issue. The FDA says that health care providers do not need to take any action as a result of the recall, and consumers may continue to use the medicine.
McNeil also issued a voluntary recall of all product lots of Children’s Benadryl Allergy Fastmelt Tablet in cherry and grape flavors that were sold in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin and St. Thomas, as well as all Junior Strength Motrin Caplets 24 count that were sold in the United States. These recalls, issued Nov. 15, are the result of a review that found insufficiencies in the development of the manufacturing process. Consumers may continue to use these products, and no action is required for health care providers, according to the FDA. There is no reason to believe that the products are unsafe, and no adverse events have been reported.
Questions about the recalls should be directed to the company’s Consumer Care Center at 1-888-222-6036.