• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

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 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 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

###

 

RSS Feed for FDA Recalls Information [what's this?]