Certain lots of infant’s and children’s Tylenol, Motrin, Zyrtec and Benadryl products are being recalled, the Food and Drug Administration said today.
McNeil Consumer Healthcare, a unit of Johnson and Johnson, is voluntarily recalling over 40 over-the-counter medications because some of them may contain more of the active drug ingredient than specified on the package. Others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles, according to McNeil’s web site.
The company said consumers should stop using certain lots of infant’s and children’s Tylenol, Motrin, Zyrtec, and Benadryl.
“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 Margaret Hamburg said in a statement.
McNeil said that there have been no adverse health reactions to the products reported so far, but they advised consumers to stop using them.
On Friday morning, federal health regulators cited McNeil for manufacturing violations found during a routine inspection at a company facility in Fort Washington, Pa.
This has been a rough year for McNeil. In January, after reports of moldy smells from over-the-counter medicines made at a Puerto Rican plant, the company recalled hundreds of lots of adult and children’s products. The earlier recall involved certain lots of Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol.
McNeil has set up a hotline, (888) 222-6036, available 8 a.m. to 10 p.m. Eastern time, Monday through Friday and on weekends from 9 a.m. to 5 p.m. to address customer questions and concerns.
Any adverse reactions may also be reported to the FDA’s MedWatch Program at www.fda.gov/medwatch.