Johnson & Johnson has recalled all infant Tylenol off the U.S. market because some parents have had problems with redesigned bottles, introduced four 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, recalled all 574,000 bottles of grape-flavored, liquid Infants’ Tylenol from stores nationwide. 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.
The company 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 McNeil at 1-888-222-6036 or www.tylenol.com. While babies are particularly vulnerable to excessive doses of medicine, J&J said there have been no reports of anyone being harmed.
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. The syringe has an opening in the tip but no needle. 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. McNeil changed the design to make it easier to get the dose right and to limit spillage if the bottle is knocked over, according to a McNeil spokeswoman.
The prior version had an open-topped bottle and a dropper with a flexible bulb at the top, similar to a turkey baster. McNeil is part of the consumer health business segment at J&J, which is based in New Brunswick, N.J. The company’s prescription drug and medical device divisions each have issued at least two recalls in the last couple of years. Reasons for the recalls have included nauseating package odors, small glass or metal particles in liquid medicines and wrong levels of active ingredients.
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