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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

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 . 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 The product lot numbers for the recalled products can be found on the side of the bottle label. FULL RECALLED PRODUCT LIST:
Product Name
BENADRYL® ALLERGY ULTRATAB™
BENADRYL® ALLERGY ULTRATAB™ TABLETS 100 count  BENADRYL® ALLERGY ULTRATAB™ TABLETS 100 count  Children’s TYLENOL® Meltaways
CHILDREN’S TYLENOL® MELTAWAYS BUBBLEGUM 30 count  MOTRIN® IB
MOTRIN® IB CAPLET bonus pack 50+25 count  TYLENOL®, Extra Strength
TYLENOL®, Extra Strength EZ TABLET 225 count  TYLENOL®, Extra Strength EZ TABLET 50 count  TYLENOL®, Extra Strength COOL CAPLET 24 count  TYLENOL®, Extra Strength CAPLET bonus pack 24+12 count  TYLENOL®, Extra Strength CAPLET 50 count  TYLENOL®, Extra Strength CAPLET 50 count   (contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC 300450444530) TYLENOL®, Day & Night Value Pack  (contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC 300450444530) TYLENOL®, Day & Night Value Pack  (contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC 300450444530) TYLENOL®, Extra Strength RAPID RELEASE GELCAP 24 count  TYLENOL®, Extra Strength RAPID RELEASE GELCAP 225 count  TYLENOL® PM
TYLENOL® PM RAPID RELEASE GELCAP 20 count 

Source: http://www.lakevillema.org/7-9-10EXPANDED%20RECALL-Benadryl%20Motrin%20Tylenol-musty%20odor.pdf

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