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McNeil Consumer Healthcare Recalls of All Lots of TYLENOL(R) Arthritis Pain 100 Count With EZ-OPEN CAP

Mon, 12/21/2009 - 3:31am
In consultation with the 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 numberscan be found on the side of the bottle label. See the full list of affectedproduct lot numbers below: 0045- 8382100 07CMC011, 07DMC022, 07DMC024, 07FMC032, TYLENOL(R)0838-21 07FMC033, 07GMC038, 07GMC039, 07HMC045, ARTHRITIS PAIN07HMC051, 07HMC053, 07JMC064, 07JMC069, CAPLET 100 COUNT07JMC070, 07JMC071, 07XMC055, 07XMC058, BOTTLES (with07XMC062, 08AMC002, 08AMC005, 08CMC026, red EZ-OPEN CAP)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 Only the TYLENOL Arthritis Pain Caplet 100's with the distinctive redEZ-OPEN CAP are affected by this action. All other TYLENOL Arthritis Painproducts remain commercially available. McNeil Consumer Healthcare willreintroduce the TYLENOL Arthritis Pain Caplet 100 count product by January,2010 after moving production to a new facility.

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