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, 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.com1 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.2

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™
BENADRYL® ALLERGY ULTRATAB™ TABLETS  100 count	ABA567	312547170338
BENADRYL® ALLERGY ULTRATAB™ TABLETS 100 count	ABA574	312547170338
Children’s TYLENOL® Meltaways
CHILDREN’S TYLENOL® MELTAWAYS BUBBLEGUM  30 count	ABA544	300450519306
MOTRIN® IB
MOTRIN® IB CAPLET 24 count	ACA003	300450481030
MOTRIN® IB CAPLET bonus pack 50+25 count	ACA002	300450481764
MOTRIN® IB TABLET 100 count	AFA060	300450463043
TYLENOL®, Extra Strength
TYLENOL®, Extra Strength  EZ TABLET 225 count	ASA206	300450422378
TYLENOL®, Extra Strength  EZ TABLET 50 count	ABA005	300450422507
TYLENOL®, Extra Strength  COOL CAPLET 24 count	ABA566	300450444240
TYLENOL®, Extra Strength  CAPLET bonus pack 24+12 count	ACA025	300450444318
TYLENOL®, Extra Strength  CAPLET 50 count	AFA018	300450449078
TYLENOL®, Extra Strength  CAPLET 50 count                                                     (included in Day/Night Pack)	ABA168	300450444530
TYLENOL®, Day & Night Value Pack (contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC  300450444530)	AEC005	300450527103
TYLENOL®, Day & Night Value Pack (contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC  300450444530)	AFC005	300450527103
TYLENOL®, Day & Night Value Pack (contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC  300450444530)	ADC002	300450527103
TYLENOL®, Extra Strength RAPID RELEASE GELCAP 24 count	ACA024	300450488244
TYLENOL®, Extra Strength RAPID RELEASE GELCAP 225 count	AJA119	300450488251
TYLENOL® PM
TYLENOL® PM CAPLET 24 count	ACA005	300450482242
TYLENOL® PM CAPLET 24 count	ADA259	300450482242
TYLENOL® PM GELTAB 50 count	AFA100	300450176509
TYLENOL® PM RAPID RELEASE GELCAP 20 count	ACA004	300450244208

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Mcneil Consumer Healthcare Recalls Four Product Lots of Benadryl® Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra Strength Tylenol® Rapid Release Gels, 50 Count

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company’s January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW). This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.

BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu.

The January 15th, 2010 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 (TBA). After a thorough investigation, it was determined that the source of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden 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, consumers should log on to the internet at www.mcneilproductrecall.com1 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). Requests for reimbursement can be made at www.mcneilproductrecall.com2. 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 http:www.fda.gov/safety/medwatch/default.htm.

The product lot numbers for the recalled products can be found on the side of the bottle label.

FULL RECALLED PRODUCT LIST:

Product Name	Product Form	Lot Number	NDC Number	UPC Code
BENADRYL Allergy ULTRATAB Tablets 100 count	Ultratab Tablet	AJA008, ADA194, ABA022, ABA264	50580-226-10	312547170338
EXTRA STRENGTH Tylenol Rapid Release Gels 50 count	Rapid Release Gelcap	ASA202	50580-488-50	300450488503

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