Johnson & Johnson’s consumer unit recalled 750,000 bottles and packages of Tylenol and other over-the-counter drugs that may have been produced on improperly cleaned equipment or tainted by a musty odor.
The McNeil Consumer Healthcare unit is recalling 34,000 bottles of Tylenol 8-hour Extended Release Caplets in the U.S. made before a Fort Washington, Pennsylvania, plant was shut down last April, Bonnie Jacobs, a spokeswoman for New Brunswick, New Jersey-based J&J, said today in an e-mail. McNeil also added 717,696 bottles and packages to a Jan. 14 recall of Tylenol, Benadryl and Sudafed that may have been made on unclean equipment, Jacobs said.
J&J, the world’s second-biggest seller of medical products, pulled more than 40 consumer brands last year, among them varieties of children’s and infants’ Tylenol, Motrin and St. Joseph Aspirin. The withdrawals cost the company $900 million in lost sales in 2010 and led to a consent decree giving U.S. regulators more oversight at three McNeil plants.
The Tylenol 8-hour recall resulted from McNeil’s “ongoing surveillance and monitoring program” following the odor problems, Jacobs said. “As a result of these enhanced surveillance efforts, we identified a small number of complaints and following a comprehensive investigation, we determined the cause of the complaints and took action to recall” one lot of the product.
The smell has been traced to trace amounts of 2,4,6-tribromoanisole and 2,4,6-trichloroanisole, the company said in a statement today. The chemicals are related to a fire retardant and pesticide used to treat wooden storage pallets, the U.S. Food and Drug Administration said last year.
“This voluntary action is being taken as a precaution and the risk of adverse medical events is remote,” the statement said.
Customers have complained of nausea, vomiting and diarrhea from the odors, J&J has said in previous statements.
J&J fell 2 cents to $59.22 at 4 p.m. in composite New York Stock Exchange trading and has lost 8.6 percent in the past 12 months. New York-based Pfizer Inc. is the biggest maker of medical products by sales.
The expansion of the Jan. 14 recall includes 180,288 bottles of Tylenol Arthritis Pain extended-release geltabs; 108,336 packages of Tylenol Sinus medicine; 207,288 bottles of Tylenol 8-hour Extended-Release; 87,216 bottles of Benadryl Allergy Sinus Headache medicine; and 134,568 packages of Sudafed PE Cold/Cough Multisymptom, Jacobs said.
The withdrawal covers 10 lots at the wholesale level, McNeil said in its statement.