NEW BRUNSWICK, N.J. -- Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Pain Caplets due to consumer reports of a moldy smell that can cause nausea and stomach pain.
According to a statement on the Food and Drug Administration Web site, the New Brunswick, N.J., company is now recalling all product lots of the Arthritis Pain Caplet 100-count bottles with the red EZ-Open Cap.
Johnson & Johnson had recalled five lots of the product last month.
The health care company says the odor results from trace amounts of a chemical called 2,4,6-tribromoanisole. That chemical is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials.
To date, the side effects, which also include vomiting and diarrhea, have been "temporary and non-serious," although the health effects of the compound have not been studied.
The recall only affects the specific lots cited. All other Tylenol Arthritis pain products remain available.
The company will reintroduce Tylenol Arthritis Pain Caplets 100 count by January after moving production to a new facility.
The affected TYLENOL® Arthritis Pain Caplet 100 count product lot numbers can be found on the side of the bottle label. Please see the full list of affected product lot numbers below:
UPC #: 0045-0838-21
Code #: 8382100
Lot #: 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
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 Web site at www.fda.gov/medwatch.
(Copyright 2009 by The Associated Press. All Rights Reserved.)
