Subject: Over-the-counter Medicine Recall
Date: 7/12/2010; 16:03:11
Message#: 101657-7-12-2010-PHIN
Contact Info: Alan L. Talarsky, NJDHSS/CEHS/Food and Drug Safety Program
Phone: 609-588-3123; Email:
at2@njlincs.netAttachments: None
Please review the following message from Alan Talarsky, Environmental Scientist 1, Food and Drug Safety Program, DHSS regarding the following Class 1 Recall issued by the U.S. Food and Drug Administration:
McNeil Consumer Healthcare, 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.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
No action is required of local health departments at this time for this recall. If any requests for assistance are received from FDA, the Food and Drug Safety Program will contact you. For additional information regarding warnings and recalls, please click on the weblink below.
**********************************************************************************
For all recalls - http://www.recalls.gov/recent.html
This information has been distributed to: DHSS Senior Staff; DHSS Staff; LINCS Coordinator Backups; LINCS Coordinators; LINCS Epidemiologists; LINCS Health Educators; LINCS Health Officer Assistants; LINCS Health Officers; LINCS Health Planners; LINCS IT Specialists; LINCS Partnership Coordinators; LINCS Public Health Nurses; LINCS Regional Health Planners; LINCS Team Members; LOCAL Health Officers; LOCAL Public Health; Food Safety Organizations
Further distribution of this message should be directed to: n/a
IMPORTANT NOTE: Please do not use reply feature of your email system. If you have questions about the content of this email or any of its attachments, please call your County/City LINCS agency for assistance. LINCS agencies are instructed to contact the individual listed in message above or on the attachment for questions concerning content.