Mcneil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the United States, Fiji, Gua

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
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.com 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.

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 ULTRATABTM    
BENADRYL® ALLERGY ULTRATABTM TABLETS  100 count ABA567
 312547170338
 
BENADRYL® ALLERGY ULTRATABTM 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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