FDA Scolds Drug Maker Over Recall

Published: Tue 19 Jan 2010

Thomas Kristoffersen

The Food and Drug Administration has blasted Johnson and Johnson about not listening to customer complaints that could have prevented the drug manufacturer from having to initiate a massive recall of products from one of its divisions.

Customers reportedly had complained that a variety of over-the-counter products by Johnson and Johnson's McNeil-PPC division had an "unusual moldy, musty or mildew-like" odor but the company had done nothing to remedy the problem. The company said it had reports of a "small" amount of such problems as diarrhea, nausea, stomach pain and vomiting.

It did not indicate when the complaints were submitted or how many were received.

Even though the complaints about the odor dated to 2008, according to the FDA, nothing was done. "When something smells bad, literally and figuratively, you aggressively investigate and solve the problem," said Deborah Autor, director of FDA's compliance office.

"The company should have acted faster," Autor said. "All companies have a responsibility to ensure high quality, safety and effectiveness of their products and protect consumers."

The recalled products include Benedryl Allergy Ultratab Tablets, Children's Tylenol Grape Meltaway Tablets, Extra Strength Rolaids Fresh Mint Tablets, Extra Strength Tylenol, Extra Strength Tylenol Rapid Release Gelcaps, Extra Strength Tylenol PM Geltabs, Junior Strength Motrin, Motrin Caplets, and St. Joseph Aspirin Chewable Orange Tablets.

McNeil reported about 500 "lots" of the products were in the recall but did not give a breakdown of which products were included. The recall affects products shipped to the Americas, Fiji and the United Arab Emirates.

McNeil has 15 days to tell the FDA how it plans to fix the problem and prevent its happening again.

The company blamed the smell on the chemical 2,4,6-tribromoanisole, or TBA, It was put on wooden pallets made in a plant in Puerto Rico and used to ship and store packaging materials used by the drug manufacturer.

Although the manufacturer reported some of the recalled drugs had TBA traces, it did not say whether the chemical composition of the drugs was changed as a result. The FDA was checking whether other drug manufacturers used the pallets to ship their products.

Customers who bought products from the affected lots were told to stop using them. The lot numbers are listed on the side of the bottles. McNeil Consumer Health Care should be contacted at 888-222-6036 or www.mcneilproductrecall.com for a refund, replacement or other questions.

Anyone with medical issues should contact a physician.