Recall Broadens To Include Extra Strength and Rolaids
A recall of several over-the-counter pain relievers including Tylenol, Benadryl, and Motrin has been announced because of complaints of a mildew or musty odor.
Johnson & Johnson has been working to fix the problem since it was first reported in 2008, reports CNN Money.
60 million bottles of Tylenol products are now included in an expanded recall announced Friday morning grew, More than two dozen over-the-counter products are all made by McNeil Healthcare LLC, a division of Johnson & Johnson.
A Bad Smell
When something smells bad, literally and figuratively, you aggressively investigate and solve the problem," said Deborah Autor, director of FDA's compliance office to CNN.
"The company should have acted faster," Autor said. "All companies have a responsibility to ensure high quality, safety and effective of their products and protect consumers."
In November, McNeil recalled five lots of Tylenol Arthritis Pain 100 count with the EZ-Open cap. In December, McNeil expanded the voluntary recall to include all lots of Tylenol Arthritis Pain Caplet with the EZ-Open cap.
At that time, some consumers had complained about stomach problems. A chemical substance called 2,4,6-tribromoanisole (TBA) is applied to wood pallets and the chemical breakdown was transferred to packaging materials.
The FDA has traced the pallets to a manufcturing plant in Puerto Rico. The agency is determining whether other drug makers also use pallets from this plant to transport products.
Included in the expanded recall are: Tylenol Extra Strength, Rolaids and a number of children’s medications. In all 27 products are affected including junior strength Motrin, Children’s Tylenol Grape Meltaway tablets, Extra Strength Tylenol, Extra Strength Tylenol, Rapid Release Gelcap, Extra Strength Tylenol PM Geltab, Motrin Caplets, Extra Strength Rolaids fresh mint tablets and St. Joseph Aspirin chewable orange tablets.
10 reports of a moldy and musty odor have been received about Rolaids and 39 about Tylenol Extra Strength, including three adverse event reports.
The musty-smelling chemical causes sickness but poses no serious risk to health.
In a statement McNeil says, “In addition to the product recall, McNeil Consumer Healthcare is continuing its investigation into the issue and is taking further actions that include ceasing shipment of products produced using materials shipped on these wood pallets and requiring suppliers who ship materials to our plants to discontinue the use of these pallets.”
Contact McNeil products toll free (888) 222-6036. #