McNeil Consumer Healthcare Recalls Benadryl Allergy Products

The FDA reported in June of 2010 in a safety alert on their website that McNeil Consumer Healthcare had initiated a recall of five lots of Benadryl Allergy Ultratab Tablets, 100 count sold in the United States and one product lot of Extra Strength Tylenol Rapid Release Gels, 50 count sold in the United States, Trinidad, Tobago, Bermuda, and Puerto Rico.

McNeil initially ordered a recall of related products in January of 2010 and issued the current recall due to an accidental omission of the above products from the initial recall. The company discovered the omission of their own accord and notified the FDA and consumers immediately upon discovering the problem.

The drugs have been recalled due to the presence of 2,4,6-tribromoanisole (TBA) in them, which was reported to have potential for adverse side effects, although company scientists have not found any evidence to substantiate that potential. The FDA Safety Alert article notes that McNeil’s “further analysis confirms that the risk of serious adverse medical events is remote.”

The initial recall in January of 2010 began after multiple customers complained of “a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA).” McNeil discovered that the chemical arose in the drugs due to a breakdown of another chemical applied to the wooden pallets used to ship and store the products.

The alert warns consumers to stop using all drugs from lots included in both recalls. Consumers are further advised to contact McNeil for refund and return instructions. Customers who used the drugs are advised to report any adverse side effects or illnesses that arose in relation to the recalled products to the FDA and McNeil.

References:

Jacobs, Bonnie. (June 15, 2010) “McNeil Consumer Healthcare Recalls Four Product Lots of Benadryl® Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra Strength Tylenol® Rapid Release Gels, 50 Count.” Retrieved on August 26, 2010 from the FDA web site.