The drugs involved – 100-count packages of Benadryl Allergy Ultratab Tablets and 50-count packages of Extra Strength Tylenol Rapid Release Gels – should have been included in the company's massive Jan. 15 recall, but they were "inadvertently omitted from the original recall," the company said in a statement.
The omission is the latest blow to the Johnson & Johnson unit, McNeil Consumer Healthcare, which has been the focus of federal and congressional investigations. In May, the Food and Drug Administration said it was considering possible criminal action against McNeil because of numerous quality lapses and delays in reporting problems linked to the Jan. 15 recall.
The musty odor was linked to a chemical used in wooden pallets that were used to store the products. But the chemical contamination was low enough that the risk of a serious adverse health effect is remote, the company says.
Consumers who think they may have bought the product should check the packages for the lot numbers. For the Benadryl product (NDC Code #50580-226-10), the four lot numbers that are being recalled are AJA008, ADA194, ABA022, and ABA264. The recall of the Tylenol product (NDC Code #50580-488-50) involves a single lot number: ASA202.
People who have purchased the recalled drugs should stop using them immediately and contact McNeil Consumer Healthcare to get a refund or replacement. The company can be reached through the Internet (www.mcneilproductrecall.com) or toll-free by phone at 888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern time, and Saturday or Sunday 9 a.m. to 5 p.m.).
IN PICTURES: Major product recalls