- Copyright © 2012, The American Academy of Pediatrics
McNeil Consumer Healthcare is recalling Infants’ Tylenol Oral Suspension in the 1 oz grape-flavored version after consumer complaints about its dosing system.
Seven lots, or about 574,000 bottles of the product, are being recalled at the wholesale and retail levels nationwide.
The product’s SimpleMeasure dosing system includes a dosing syringe that a parent or caregiver inserts into a protective cover, or flow restrictor, at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle while consumers were inserting the syringe.
Lot numbers of the recalled products are as follows: BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00. The UPC code is 300450122308.
Infants’ Tylenol products can continue to be used only if the flow restrictor at the top of the bottle remains in place, but not if the flow restrictor is pushed into the bottle.
The firm said no adverse events have been reported to date, and the risk of a serious adverse medical event is remote.
To request a refund or for more information, visit www.tylenol.com or call McNeil at 888-222-6036. Parents also can contact their pediatrician with questions.
Read the recall notice and find a link on how to use the dosing system, plus other resources, at www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tylenol_recall_8.inc.
Report any adverse events to the Food and Drug Administration MedWatch Safety Program online at www.fda.gov/MedWatch/report.htm or call 800-332-1088 to request a reporting form.