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 (see full product
list below). 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 TYLENOL® - The official website for all TYLENOL® products
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 TYLENOL® - The official website for all TYLENOL® products for additional information.
Product Name: Infants' TYLENOL® Oral Suspension 1oz. Grape
Lot Numbers: BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00
UPC Code: 300450122308
For full details please see: Tylenol.com
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