All Lots of Tylenol Arthritis Pain 100-count With EZ-OPEN Cap Bottles Recalled

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McNeil Consumer Healthcare is expanding its recall to include all available product lots of Tylenol Arthritis Pain Caplet 100-count bottles with the red EZ-OPEN cap.

In November, the company recalled five lots of this product due to consumer reports of an unusual moldy, musty or mildew-like odor associated with nausea, stomach pain, vomiting and diarrhea. The recall is being expanded to include all available lots as a precaution.

The uncharacteristic smell is caused by the presence of trace amounts of the chemical 2,4,6-tribromoanisole. The source of this chemical 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 studied well, and to date all the observed events reported to McNeil were temporary and not serious.

The affected lot number is printed on the side of the bottle label. Here is the full list of the recalled product lot numbers:

• 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 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 about returning or disposing of the product, consumers should call 888-222-6036 to speak with a customer service representative available Monday through Friday from 8 a.m. to 8 p.m. EST and on Saturdays and Sundays from 9 a.m. to 5 p.m. Consumers can also log visit www.tylenol.com.

Consumers who have medical concerns or questions should contact their health care provider.

Any adverse reactions may also be reported to the FDA's MedWatch Program:

• By fax: 800-FDA-0178
• By postal mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
• Online: www.fda.gov/medwatch

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.

Contact:
Marc Boston
215-273-7649