McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. (“McNeil”), is voluntarily recalling, at the wholesale and retail levels, seven lots, approximately 574,000 bottles, of Infants’ TYLENOL® Oral Suspension, 1 oz. Grape distributed nationwide in the United States. Infants’ TYLENOL® is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer.
McNeil is initiating this voluntary recall as a precaution after receiving a small number of complaints from consumers who reported difficulty using the Infants’ TYLENOL® SimpleMeasure™ dosing system. SimpleMeasure™ includes a dosing syringe, which 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 when inserting the syringe.
Children’s TYLENOL® products are intended for children two years of age and older and remain available.
No adverse events associated with this action have been reported to date and the risk of a serious adverse medical event is remote.
Consumers can continue to use Infants’ TYLENOL® provided the flow restrictor at the top of the bottle remains in place. The company discussed how to use the product’s dosing system in a separate message to consumers also issued today.
If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. Consumers can request a refund by visiting www.tylenol.com or contacting McNeil at 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time; Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).
Parents and caregivers with any health questions or concerns should contact their healthcare provider and visit www.tylenol.com for additional information.
Adverse events that may be related to the use of this product may be reported to U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
•Online: www.fda.gov/medwatch/report.htm
•Regular mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
•Fax: 1-800-FDA-0178
