Instead, some parents have complained that a protective cover on the top of the bottles meant to limit how much liquid pain reliever could be drawn into a plastic syringe didn't work correctly. When those consumers inserted the plastic syringe, it pushed the protective cover, or flow restrictor, into the bottle.
J&J's McNeil Consumer Healthcare, plagued by about 25 product recalls since September 2009, said Friday that it is recalling all 574,000 bottles of a grape-flavored version of the liquid medicine on the market. The product, which was distributed nationally, was introduced in November.
It's one of the first nonprescription medicines reintroduced after all the recalls and an ongoing factory shutdown have kept most of McNeil's medicines off the market for well over a year, costing the company well over $1 billion in lost revenue, plus many millions for ongoing factory improvements.
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. 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, McNeil spokeswoman Barbara Montresor said. 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 medicial device divisions each have issued at least two recalls in the last couple years.