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AAFES RECALL  NO. 10-051
RELEASE DATE:
09 July, 2010
SUBJECT: QA HAZARDOUS RECALL – MCNEIL CONSUMER HEALTHCARE ANNOUNCES VOLUNTARY RECALL OF VARIOUS OTC PRODUCTS

SCOPE: WORLDWIDE

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling 21 lots of over-the-counter (OTC) medicines. The lots involved, as listed below link, are sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica.

ISSUE: This recall action is a follow-up to a product recall that McNeil Consumer Healthcare originally announced on January 15, 2010, which was initiated following consumer complaints of a musty or moldy odor, which has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). The risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

INCIDENTS/INJURIES: There have been no incidents reported to date.

PRODUCT INFORMATION: Certain lots of the OTC items have been recalled. To view the entire list of recalled products click here (http://www.fda.gov/Safety/Recalls/ucm218437.htm).

REMEDY/CONSUMER INFO: Consumers should immediately stop using the affected product and contact the McNeil Consumer Call Care Center for a refund or replacement at: 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) or log on to the internet at: www.mcneilproductrecall.com. Consumers who have medical concerns or questions should contact their healthcare provider.

 


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