AUDIENCE: Consumer, Pharmacy
ISSUE: McNeil Consumer Healthcare notified the
public of a recall of seven lots (approximately 574,000 bottles) of
Infants’ TYLENOL Oral Suspension, 1 oz. Grape. There were
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.
BACKGROUND: Infants’ TYLENOL is an
over-the-counter (OTC) product indicated as a pain reliever/fever
reducer. The product was distributed nationwide in the United
States.
RECOMMENDATION: If the flow restrictor is
pushed into the bottle, the parent or caregiver should not use the
product. See the Press Release for lot number and UPC codes of
affected product. Consumers can visit www.tylenol.com
for additional information.
Healthcare professionals and patients are encouraged to report
adverse events or side effects related to the use of these products
to the FDA's MedWatch Safety Information and Adverse Event
Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
-
Download form or call 1-800-332-1088 to request a reporting
form, then complete and return to the address on the pre-addressed
form, or submit by fax to 1-800-FDA-0178
[02/17/2012 - Press
Release - McNeil Consumer Healthcare]
[02/17/2012 - Product
Photo - FDA]
SOURCE