FDA reports that McNeil Consumer Healthcare, who has been involved in recent children’s medicine recalls, is expanding its recall to include five more product lots.
On June 15, 2010, McNeil Consumer Healthcare, announced the recall of the 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. The product lot numbers for the recalled products can be found on the side of the bottle label. All these products were produced before the January 15th, 2010 recall.
This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 because these newly recalled products were mistakenly left out of the initial recall action. McNeil Consumer Healthcare informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list.
The January 15th, 2010 recall was the result of consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical resulting from of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.
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.
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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