Tylenol Arthritis Pain Caplet 100 Count Recall

[Guest guest]

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 A Voluntary Nationwide Recall Of All Lots

Of Tylenol® Arthritis Pain 100 Count With Ez-Open Cap

 

Company Contact:

Marc Boston

215-273-7649 (office)

215-429-7034 (mobile)

 

Bonnie s

215-273-8994 (office)

856-912-9965 (mobile)

 

FOR IMMEDIATE RELEASE – December 18, 2009 – Fort Washington, PA – In

consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer

Healthcare, Division of McNEIL-PPC, Inc., is expanding its voluntary recall to

include all available product lots of TYLENOL® Arthritis Pain Caplet 100 count

bottles, with the distinctive red EZ-OPEN CAP  (Full list of lot numbers

provided below). In November 2009, 5 lots of this product were recalled due to

consumer reports of an unusual moldy, musty, or mildew-like odor that was

associated with nausea, stomach pain, vomiting and diarrhea.  The recall is

being expanded, as a precaution, to include all TYLENOL® Arthritis Pain Caplet

100 count bottles with the distinctive red EZ-OPEN CAP.

 

The uncharacteristic smell is caused by the presence of trace amounts of a

chemical called  2,4,6-tribromoanisole.  The source of 2,4,6-tribromoanisole

is believed to be the breakdown of a chemical used to treat wooden pallets that

transport and store packaging materials. The health effects of this compound

have not been well studied, and to date all of the observed events reported to

McNeil were temporary and non-serious.           

 

Consumers who purchased TYLENOL® Arthritis Pain Caplet 100 count bottles with

the distinctive red EZ-OPEN CAP from the lots included in this recall should

stop using the product and contact McNeil for instructions on a refund or

replacement.   For these instructions or information regarding how to return

or dispose of the product, consumers should 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)

or log on to the internet at www.tylenol.com.  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, FDA, 5600 Fishers Lane, Rockville, MD

20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

 

The affected TYLENOL® Arthritis Pain Caplet 100 count product lot numbers can

be found on the side of the bottle label. See the full list of affected product

lot numbers below:

 

Recalled Product- Full List (LINK:

http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tar_recall.inc

 

UPC # NDC Code # Lot # Product Description

0045-0838-21 8382100 07CMC011, 07DMC022, 07DMC024, 07FMC032, 07FMC033, 07GMC038,

07GMC039, 07HMC045, 07HMC051, 07HMC053, 07JMC064,  07JMC069, 07JMC070,

07JMC071, 07XMC055, 07XMC058, 07XMC062, 08AMC002, 08AMC005, 08CMC026, 08DMC029,

08EMC037, 08EMC039, 08FMC044, 08FMC045, 08GMC050, 08GMC053, 08GMC063, 08GMC065,

08JMC103, 08JMC109, 08JMC110, 08JMC111, 08KMC124, 08KMC127, 08KMC131, 08KMC132,

08XMC093, 08XMC094, 08XMC095, 09AMC010, 09CMC041, 09EMC075, 09EMC079, 09EMC076,

09GMC096, 09GMC097, 09GMC099, 09JMC118, 09JMC126, 09KMC133, 09KMC134, 09XMC114,

09XMC116 TYLENOL® ARTHRITIS PAIN CAPLET 100 COUNT BOTTLES

 

(with red EZ-OPEN CAP)

 

Only the TYLENOL® Arthritis Pain Caplet 100’s with the distinctive red

EZ-OPEN CAP are affected by this action.  All other TYLENOL® Arthritis Pain

products remain commercially available. McNeil Consumer Healthcare will

reintroduce the TYLENOL® Arthritis Pain Caplet 100 count product by January,

2010 after moving production to a new facility.  

 

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. markets a broad range

of well-known and trusted over-the-counter (OTC) products around the globe.

McNeil Consumer Healthcare is most widely recognized for the complete line of

TYLENOL® acetaminophen products, the leading pain reliever brand in the adult

and pediatric categories. 

 

 

http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tar_recall.inc