A faulty part of the dosing system -- an interior cap called a "flow restrictor" -- can get pushed down into the bottle. This interferes with the syringe used to measure each dose. It could result in kids getting too much or too little acetaminophen, the painkiller/fever-reducer that is Tylenol's active ingredient.
The recall affects seven lots of infants' Tylenol Oral Suspension 1 oz. Grape, sold over the counter across the U.S. The recalled infant Tylenol:
- Has the UPC code 300450122308
- Has lot numbers BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, or BJL2U00
The product should not be used if the interior cap has been pushed down into the bottle. If the cap is intact, the product may be used.
"We apologize to parents and caregivers who have found our SimpleMeasure dosing system hard to use," McNeil president Denice Torres said in a news release.
McNeil says that it has not heard of anyone being harmed by the recalled product. "The risk of a serious adverse medical event is remote," a company news release says. However, the company admits it has received several complaints about the faulty SimpleMeasure system.
The system works by pushing the dosing syringe into the flow restrictor, then turning the bottle upside down and using the syringe to draw the correct dose. It's a new system, ironically put in place to reduce the risk of overdose.
The company is offering a refund to consumers who contact McNeil at its Tylenol web site or by calling 888-222-6036.
This is the latest in a string of recalls of Tylenol and other Johnson & Johnson products involving familiar brands such as Rolaids, and Tylenol products for arthritis, cold and flu, allergies, and sinus pain.
More information on the recall, and a video demonstrating how to use the product’s dosing system, can be found at www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tylenol_recall_9.inc