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Beadryl Motrin and Tylenol Recall Follow up and Add on



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Shalshelet




 
 
    
 

Post Wed, Jul 14 2010, 12:18 pm
http://www.kashrut.com/Alerts/?alert=A3105

The following revised health alert is from the FDA on July 8, 2010.

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., Fort Washington, PA 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™


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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