Problems with the manufacturing of dispensing devices and the bottling process may cause medical issues to infants due to over dosing, says Alabama liability attorney Keith T. Belt
Problems with a safety feature recently added to bottles of grape-flavored liquid Infants’ Tylenol (oral acetaminophen suspension) have prompted McNeil Consumer Healthcare to recall 574,000 bottles, the company said Friday.
According to McNeil, a unit of Johnson & Johnson, “a small number of complaints from consumers” reported difficulty with a system intended to provide precise dosing of the product. The system uses a dosing syringe that is supposed to be inserted into a flow-restricting cover on top of the bottle.
“In some cases, the flow restrictor was pushed into the bottle when inserting the syringe,” McNeil said.
The system was developed in response to calls from drug safety advocates and the FDA to provide more precise dosing systems for liquid children’s medications, after studies showed that over- and under-dosing were common with spoons and cups.
McNeil said it had not received any reports of adverse events resulting from the problem, and the recall is only at the level of wholesale and retail distribution.
“Consumers can continue to use Infants’ Tylenol provided the flow restrictor at the top of the bottle remains in place,” the company said.