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Topic summary

Posted by GingerPye
 - September 14, 2011, 12:28:41 PM
http://allergy.hyperboards.com/action/view_topic/topic_id/15880

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

Contact:
Consumer Inquiries - 1(888) 222-6036
Media Inquiries - Bonnie Jacobs
(215) 273-8994 -office
(856) 912-9965 - mobile

FOR IMMEDIATE RELEASE -- 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 http://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 http://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

More info here:
http://money.cnn.com/2010/06/22/news/companies/tylenol_plant_inspection_history/index.htm