Thursday, June 17, 2010
Allergy and pain relief medicine is being recalled, according the U.S. Food and Drug Administration.
McNeil Consumer Healthcare is recalling five over-the-counter medications, in addition to products included in the company's Jan. 15 recall.
The additional lots involved are four lots of Benadryl Allergy Ultratab, 100 count bottles, sold in the U.S.; one lot of Extra Strength Tylenol Rapid Release Gels, 50 count, sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico.
These products were inadvertently omitted from the initial recall action, officials said in a press release.
The January recall was initiated as a result of consumer complaints 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. After a thorough investigation, it was determined that the source of the chemical was the result of a breakdown of a treatment applied to wood used to build pallets that transport and store product packaging materials.
Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, go to www.mcneilproductrecall.com1 or call 1-888-222-6036. Requests for reimbursement can be made at www.mcneilproductrecall.com2.
Consumers who have medical concerns or questions should contact their health care provider. Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/safety/medwatch/default.htm.
For more information, including lot numbers, go to www.fda.gov/Safety/Recalls/ucm215921.htm. The product lot numbers can be found on the side of the bottle label.