October 18, 2010
McNeil Consumer Healthcare, one of the Johnson & Johnson Family of Companies, has issued a recall of Tylenol 8HR caplets due to consumer complaints of a musty smell, the same smell that triggered recalls of other products during the past year.
This is the sixth time that McNeil issued a recall due to an off odor of their products. Consumers have reported health effects such as gastrointestinal events including nausea, stomach pain, vomiting or diarrhea from this odor in the past.
The initial odor problem was revealed when McNeil recalled certain lots of 100ct Tylenol Arthritis Pain with EZ-Open Cap in November 2009 due to a musty smell that made consumers sick, and expanded that recall in December of 2009 to include all lots of the product.
After an investigation of the odor, McNeil found that trace amounts of a chemical called 2,4,6-tribromoanisole (TBA) caused the problem, created by the breakdown of a chemical used to treat build wood pallets that transport and store product packaging materials.
In January 2010, the drug maker expanded the recall again to include various Children’s Motrin, Children’s Tylenol, Benadryl, Extra Strength Tylenol, Motrin, Regular Strength Tylenol, Rolaids, Simply Sleep, St. Joseph Aspirin, Tylenol 8-hour, Tylenol Arthritis and Tylenol PM.
In June 2010, McNeil added lots of Benadryl Allergy Ultratab Tablets and Extra Strength Tylenol Rapid Release Gels because the company inadvertently omitted the products from the January recall list.
In July 2010, the recall expanded to include 21 additional lots of Tylenol, Motrin and Benadryl products.
For a complete list of all recalled products, visit http://www.mcneilproductrecall.com/
Today’s recall involves:
TYLENOL 8 HOUR CAPLET – 50 COUNT
NDC Code # 50580-297-50
UPC # 3 0045-0297-51 8
LOT # BCM155
“This voluntary action is being taken as a precaution and the risk of adverse medical events is remote,” McNeil said in a release. “To date, observed events reported to McNeil for this lot were temporary and non-serious.”
Consumers should stop using the recalled product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036. Consumers can receive either a refund for the average retail price of the product or a product coupon.
Consumers who have medical concerns or questions should contact their healthcare provider and report any adverse reactions to the U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm or by Fax: 1-800-FDA-0178.