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| McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OT McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica Contact: Consumer Inquiries - 1(888) 222-6036 Media Inquiries - Bonnie Jacobs (215) 273-8994 -office (856) 912-9965 - mobile FOR IMMEDIATE RELEASE -- Fort Washington, PA (July 8, 2010) – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling 21 lots of over-the-counter medicines. The lots involved, listed below, are sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica. This 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). These lots are being added to the list of recalled products as a precautionary measure after a continuing internal review determined that some packaging materials used in the lots had been shipped and stored on the same type of wooden pallet that was tied to the presence of TBA in earlier recalled lots. All lots involved in the recall were produced before the January 15, 2010 recall, after which McNeil stopped accepting shipments of materials from its suppliers on that type of pallet. 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, and information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com9 or call 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). Consumers who have medical concerns or questions should contact their healthcare 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.10 The product lot numbers for the recalled products can be found on the side of the bottle label. FULL RECALLED PRODUCT LIST: Product Name Lot Number UPC Code BENADRYL® ALLERGY ULTRATAB™ TABLETS 100 count ABA567 312547170338 ABA574 312547170338 CHILDREN’S TYLENOL® MELTAWAYS BUBBLEGUM 30 count ABA544 300450519306 MOTRIN® IB CAPLET 24 count ACA003 300450481030 ACA002 300450481764 AFA060 300450463043 TYLENOL®, Extra Strength EZ TABLET 225 count ASA206 300450422378 ABA005 300450422507 ABA566 300450444240 ACA025 300450444318 AFA018 300450449078 (included in Day/Night Pack) ABA168 300450444530 (contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC 300450444530) AEC005 300450527103 (contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC 300450444530) AFC005 300450527103 (contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC 300450444530) ADC002 300450527103 ACA024 300450488244 AJA119 300450488251 TYLENOL® PM CAPLET 24 count ACA005 300450482242 ADA259 300450482242 AFA100 300450176509 ACA004 300450244208 ### |
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