[Tif-mail] Hatzolah Notice - Recalled drugs

[Milchman, Paul]

The following revised health alert is from the FDA<http://www.fda.gov/Safety/Recalls/ucm218437.htm> on July 8, 2010.

[http://www.kashrut.com/Alerts/benedril.jpg]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(r) ALLERGY ULTRATAB(tm)








BENADRYL(r) ALLERGY ULTRATAB(tm) TABLETS  100 count


ABA567


312547170338


BENADRYL(r) ALLERGY ULTRATAB(tm) TABLETS 100 count


ABA574


312547170338


Children's TYLENOL(r) Meltaways








CHILDREN'S TYLENOL(r) MELTAWAYS BUBBLEGUM  30 count


ABA544


300450519306


MOTRIN(r) IB








MOTRIN(r) IB CAPLET 24 count


ACA003


300450481030


MOTRIN(r) IB CAPLET bonus pack 50+25 count


ACA002


300450481764


MOTRIN(r) IB TABLET 100 count


AFA060


300450463043


TYLENOL(r), Extra Strength








TYLENOL(r), Extra Strength  EZ TABLET 225 count


ASA206


300450422378


TYLENOL(r), Extra Strength  EZ TABLET 50 count


ABA005


300450422507


TYLENOL(r), Extra Strength  COOL CAPLET 24 count


ABA566


300450444240


TYLENOL(r), Extra Strength  CAPLET bonus pack 24+12 count


ACA025


300450444318


TYLENOL(r), Extra Strength  CAPLET 50 count


AFA018


300450449078


TYLENOL(r), Extra Strength  CAPLET 50 count

(included in Day/Night Pack)


ABA168


300450444530


TYLENOL(r), Day & Night Value Pack

(contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC  300450444530)


AEC005


300450527103


TYLENOL(r), Day & Night Value Pack

(contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC  300450444530)


AFC005


300450527103


TYLENOL(r), Day & Night Value Pack

(contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC  300450444530)


ADC002


300450527103


TYLENOL(r), Extra Strength RAPID RELEASE GELCAP 24 count


ACA024


300450488244


TYLENOL(r), Extra Strength RAPID RELEASE GELCAP 225 count


AJA119


300450488251


TYLENOL(r) PM








TYLENOL(r) PM CAPLET 24 count


ACA005


300450482242


TYLENOL(r) PM CAPLET 24 count


ADA259


300450482242


TYLENOL(r) PM GELTAB 50 count


AFA100


300450176509


TYLENOL(r) PM RAPID RELEASE GELCAP 20 count


ACA004


300450244208

The previous alert can be cited with the URL: http://www.kashrut.com/Alerts/?alert=A3105








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