The Food and Drug Administration (FDA) said May 1 that it was investigating the products and facilities involved in the voluntary recall of more than 40 varieties of liquid medication for children and infants, including Tylenol, Motrin, Benadryl and Zyrtec.
The recall, issued late on April 30 by McNeil Consumer Healthcare, a unit of Johnson & Johnson, is due to manufacturing deficiencies that may affect quality, purity or potency, the FDA said in a statement. Some products may contain a higher concentration of active ingredient than specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles, according to the McNeil product recall website, which has the full list of recalled products.
The FDA said the risk of a serious medical event was remote — and McNeil said the recall was a precautionary measure — but parents are advised not to use any unexpired lots of the recalled medications. Parents who have recently given the products to their children should alert their doctor if the child shows unexpected symptoms.
As a substitute, the FDA suggests using generic versions of the recalled products, which are intended for infants and children. Parents should not use adult-strength versions of Tylenol, Motrin or their generic counterparts.
This is not the first major recall for McNeil this year. In January, following reports of moldy-smelling bottles and a few instances of nausea, vomiting and stomach pain, the company recalled several hundred batches of adult and children’s medicines, including Tylenol, Motrin, Benadryl, Rolaids and St. Joseph Aspirin.
The New York Times reports that the current recall came after federal health regulators cited McNeil on the morning of April 30 for manufacturing violations found during a routine inspection at a company facility in Fort Washington, Pa.
For more information, consumers may call the McNeil hotline at 888-222-6036 (between 8 a.m. and 10 p.m. Monday through Friday, and between 9 a.m. and 5 p.m. Saturday and Sunday). Any adverse reactions may also be reported to the FDA’s MedWatch Program: by fax at 800-FDA-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852; or online at www.fda.gov/medwatch.