TRENTON, N.J. - Recall-plagued Johnson & Johnson is pulling all infant Tylenol off the U.S. market because some parents have had problems with redesigned bottles, introduced three months ago, that the company touted as a big safety improvement to make measuring doses easier.
Instead, 17 parents or caregivers have complained that a protective cover on the top of the bottles didn't work correctly. It's meant to limit how much of the liquid pain and fever reducer can be drawn into a plastic syringe. But when those consumers inserted the plastic syringe, it pushed the protective cover, or flow restrictor, into the bottle.
J&J's McNeil Consumer Healthcare unit, which has had about 25 product recalls since September 2009, said Friday that it is recalling all 574,000 bottles of grape-flavored, liquid Infants' Tylenol from stores nationwide.
"Today's news about the Infants' Tylenol recall is clearly disappointing after all the progress that McNeil has been making to ensure its products meet the highest level of quality and consumer satisfaction," CEO William Weldon said in a statement.
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Last spring, Weldon told shareholders at J&J's annual meeting that the company was simplifying the packaging to "help a mom, dad or caregiver ensure the correct dosing."
Infants' Tylenol is one of the first nonprescription medicines reintroduced after all the recalls and an ongoing factory shutdown have kept most McNeil medicines off the market, some for nearly two years. That's cost the company well over $1 billion in lost revenue, plus many millions to rebuild one factory and upgrade others.
McNeil spokeswoman Bonnie Jacobs said it was too soon to say when the product will return to the market.
The new infant Tylenol bottle comes with a plastic syringe that's to be inserted into the flow restrictor at the top to help measure the right dose.
Consumers are to insert the tip of the syringe into the flow restrictor, turn the bottle upside down and then draw out the right dose using the milliliter markings on the syringe. That's then squirted into the baby's mouth.
What to do
Johnson & Johnson said customers can continue to use the infant Tylenol if the bottle's flow restrictor remains intact. If not, they can request a refund by contacting J&J's McNeil Consumer Healthcare at: 1-888-222-6036 or www.tylenol.com
