This does NOT affect our own Premier
Value Brand generic equivalents
February 17, 2012
McNeil Consumer Healthcare Announces Voluntary
Nationwide Recall of
Infants' TYLENOL® Oral Suspension, 1 oz. Grape Due to
Dosing System Complaints
Recall Limited to Wholesale and Retail Levels
Washington, PA (February 17, 2012) – 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.
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.
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.
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
RECALLED PRODUCT LIST:
|Infants' TYLENOL® Oral Suspension 1oz. Grape
||BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00
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:
voluntary recall is being conducted with the knowledge of the FDA.
HERE TO SEE
FREQUENTLY ASKED QUESTIONS
HERE TO REQUEST A
INFORMATION ON INFANTS' TYLENOL® SIMPLEMEASURE™
INFORMATION ABOUT OTHER TYLENOL® RECALLS