Dosing System Problems Prompt Recall of Infants' Tylenol Oral Suspension

February 21, 2012 02:40 pm News Staff

McNeil Consumer Healthcare is voluntarily recalling(www.fda.gov) more than half a million bottles of its Infants' Tylenol Oral Suspension, 1 oz. Grape, after parents complained that the product's new dosing system is difficult to use and may malfunction.

The system, dubbed SimpleMeasure, includes a dosing syringe that parents insert into a flow restrictor at the top of the bottle to ensure the proper dose is dispensed. In some cases, however, the flow restrictor is pushed into the bottle when the syringe is inserted.

More information about the products recalled, including the affected lot numbers and Universal Product Code, is available on McNeil's Tylenol website(www.tylenol.com).

No adverse events have been reported to date as a result of this issue, and the risk of adverse events is remote, according to McNeil. Parents and caregivers can continue to use the product if the flow restrictor stays in place when the syringe is inserted. But if the flow restrictor becomes dislodged, the product should not be used.

The manufacturer has provided specific guidance on using the dosing system on its product website.

The problem affects only this particular Infants' Tylenol product; Children's Tylenol products, which use a different dosing system, are not included in the current recall.

Consumers may request a refund online(www.mcneilproductrecall.com) or by contacting McNeil at (888) 222-6036 (Monday-Friday, 8 a.m.-8 p.m. EST; Saturday-Sunday, 9 a.m.-5 p.m. EST).


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