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MORE FDA McNEIL BENADRYL & TYLENOL RECALLS
Dear Ones:
When it comes to my DOHM NEWSLETTER, no news is good news. Recently there has not been much to report on for consumers, but here is some current FDA recall information. New wooden pallets (skids) are treated with TBA, which to me smells like a combination of coal tar and (sorry about this)...vomit. This smell takes forever to dissipate, even in a well-ventilated warehouse. The fact that McNeil products were 'contaminated' means that packaging used was inadequate as a barrier guard and/or those wooden pallets were 'overtreated' and/or product on those pallets was stored in a too-hot and/or improperly ventilated storage area.
In any case, the odor is very unpleasant and TBA should not be ingested at any concentration. Stay tuned for updates as they are available--Rev. Barb--Mcneil Consumer Healthcare Recalls Four Product Lots of Benadryl® Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra Strength Tylenol® Rapid Release Gels, 50 Count http://www.fda.gov/Safety/Recalls/ucm215921.htm
Fort Washington, PA - June 15, 2010 -
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company’s January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW).
--This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.
BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu.
--The January 15th, 2010 recall was initiated as a result of consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the source of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.
--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 or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com1 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). Requests for reimbursement can be made at www.mcneilproductrecall.com2. 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 Product Form Lot Number NDC Number UPC Code
BENADRYL Allergy ULTRATAB Tablets 100 count Ultratab Tablet AJA008, ADA194, ABA022, ABA264 50580-226-10 312547170338
EXTRA STRENGTH Tylenol Rapid Release Gels 50 count Rapid Release Gelcap ASA202 50580-488-50 300450488503
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