Several hundred batches of over-the-counter drugs are being recalled by McNeil Consumer Healthcare, Division of McNEIL-PPC Inc.
The drugs include Children’s Motrin, Children’s Tylenol, Benadryl, Extrastrength Tylenol, Motrin IB, Regular Strength Tylenol, Rolaids, Simply Sleep, St. Joseph Aspirin, Tylenol 8 Hour, Tylenol Arthritis, and Tylenol PM.
McNeil Consumer Healthcare initiated the recall after consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with stomach problems, which the company said were temporary. The symptoms include nausea, stomach pain, vomiting, or diarrhea.
McNeil determined that the reported smell is caused by trace amounts of a chemical called 2,4,6-tribromoanisole or TBA. TBA can result from the breakdown of a chemical that is applied to wood in wood pallets, which transport and store packaging materials.
The health effects of TBA haven’t been well studied, McNeil said in an announcement on the recall, adding no serious illnesses have been reported in medical journals.
In December, McNeil recalled all lots of Tylenol Arthritis Pain 100 count with EZ-Open Cap due to the moldy smell. It has now identified more lots that may be affected.
Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement.
For information on how to return or dispose of the products, consumers should visit www.mcneilproductrecall.com or call 888-222-6036 Monday through Friday from 8 a.m. to 10 p.m. ET, and Saturday and Sunday from 9 a.m. to 5 p.m. ET.
Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions should be reported to the FDA’s MedWatch Program by fax at 800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Click here for information on the affected product lot numbers, which can be found on the side of the bottle label.
