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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