Alerts
McNeil Consumer Healthcare Recall of OTC Products Due to Possible Chemical Contamination - Updated
October 20, 2010
McNeil Consumer Healthcare is recalling several lots of OTC products because of consumer reports of an unusual musty, mildew odor. Some consumers experienced nausea, diarrhea, vomiting and stomach pain associated with the odor; these effects were temporary and not serious. This unusual smell is caused by trace amounts of 2,4,6-tribromoanisole, a chemical that is likely coming from the wooden pallets used for transportation and storage of the product.
In December 2009, all lots of acetaminophen (Tylenol®) Arthritis Pain with the red EZ-open cap were recalled. McNeil expanded the recall in January 2010 and July 2010 to include other products, regardless of whether the products were associated with consumer complaints. The recalled products include Children’s Motrin, Children’s Tylenol, Benadryl, Extra and Regular Strength Tylenol, Motrin IB, Rolaids, Simply Sleep, St. Joseph Aspirin, Tylenol 8-hour, Tylenol Arthritis, and Tylenol PM. A list of recalled lots can be found through the following link: http://www.fda.gov/downloads/Safety/Recalls/UCM197813.pdf. An additional Tylenol 8-hour 50 count lot (BCM155; UPC 300450297518) was recalled in October 2010.
Encourage consumers to contact their primary caregiver with any questions or concerns. Consumers who have purchased affected products should stop using them. Consumers may contact McNeil at https://www.mcneilproductrecall.com/page.jhtml?id=/include/replacement_coupon.inc or 1-888-222-6036 for information on returning products for refund or replacement; the phone line is available weekdays from 8:00 AM to 8:00 PM and weekends from 9:00 AM to 5:00 PM Eastern Standard Time. See link below for a list of all affected lot numbers.
Additional information is available at the following links:
- Information from Manufacturer:
http://www.mcneilproductrecall.com/ - Recall Expansion Notice, July 2010:
http://www.mcneilproductrecall.com/page.jhtml?id=/include/news_july.inc - MedWatch Alerts:
- January 2010:
http://www.fda.gov/Safety/Recalls/ucm197746.htm - October 2010:
http://www.fda.gov/Safety/Recalls/ucm230135.htm
Updated
October 20, 2010; July 9, 2010; January 19, 2010; December 29, 2009; December 23, 2009; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.
