Expanded Recall: McNeil Consumer Healthcare One Product Lot of TYLENOL? 8 Hour Caplets 50 Count

[Missouriwatcher]

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.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? TABLETS 100 count (ABA567) 312547170338
BENADRYL? ALLERGY ULTRATAB? TABLETS 100 count (ABA574) 312547170338
CHILDREN?S TYLENOL? MELTAWAYS BUBBLEGUM 30 count (ABA544) 300450519306

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 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 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

http://www.fda.gov/Safety/Recalls/ucm218437.htm

Also see: http://www.fda.gov/downloads/Safety/.../UCM197813.pdf

[Missouriwatcher]

Re: Expanded Recall: McNeil Consumer Healthcare One Product Lot of TYLENOL? 8 Hour Caplets 50 Count

McNeil Consumer Healthcare Announces Voluntary Recall of One Product Lot of TYLENOL? 8 Hour Caplets 50 Count Sold in The United States and Puerto Rico
October 18, 2010- Fort Washington, PA ? McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling one product lot of TYLENOL? 8 Hour caplets 50 count bottles to the retail level. McNeil is taking this action following a small number of complaints of a musty or moldy odor. The uncharacteristic odor is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. This voluntary action is being taken as a precaution and the risk of adverse medical events is remote. To date, observed events reported to McNeil for this lot were temporary and non-serious.

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

FULL RECALLED PRODUCT LIST:
Product Name/ Lot Number/ UPC Code:
Tylenol? 8 Hour Caplet 50 count/ BCM155/ 3 0045-0297-51 8



Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com9 or by calling 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) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.

http://www.fda.gov/Safety/Recalls/ucm230135.htm