October 19th, 2010
The maker of Benadryl and Tylenol has added another popular over-the-counter drug to its growing list of recalled products.
The latest recall affects Tylenol 8-hour caplets 50 count, sold in the United States and Puerto Rico. The lot number is BCM155.
Complaints of a musty or moldy odor led to the recall, McNeil Consumer Healthcare said. The odor, the company believes, is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole.
McNeil said the “risk of adverse medical events is remote.”
Adverse event reports are consumer complaints of a serious side effect associated with the use of a medical product, according to the U.S. Food and Drug Administration.
Adverse events could include death, hospitalization, disability and other health complications.
The Johnson and Johnson subsidiary said customers should call 1-888-222-6036 or use the website www.mcneilproductrecall.com for information on how to receive a refund or replacement product.
The company has issued several recalls this year of non-prescription cold and pain drugs such as Tylenol, Benadryl and Motrin — prompting a Congressional inquiry.
In November, five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for unusual odor leading to nausea, stomach pain, vomiting and diarrhea.
In December, the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.
In January, the recall was widened to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor.
In May, 50 children’s versions of these nonprescription medicines were also recalled because of quality and safety concerns. Following the pediatric medicine recall, Johnson and Johnson suspended production at McNeil’s facility in Fort Washington, Pennsylvania, that manufactured the children’s drugs.
Last month, Johnson and Johnson CEO William Weldon delivered both a mea culpa and clear admission to lawmakers that his company let the public down through numerous recent drug recalls.