Wilson County News
Consumer Updates blog header
Wilson County News • 1012 C St • Floresville • TX • 78114 • Ph: 830-216-4519 • Fax: 830-393-3219 • Email:
Tuesday, Sep 16, 2014
Login
Not a subscriber? Click here.
Are you a WCN subscriber?
Set up your password.

 
E-Mail
Password
  Remember me
 
  Forgot password?
La Vernia News
Google
Google

Preview the Paper
Preview this week's Paper

Consumer Updates

Flow-restrictor issue prompts Infants Tylenol recall




E-Mail this Story to a Friend
Print this Story

Disclaimer:
The author of this entry is responsible for this content, which is not edited by the Wilson County News or wilsoncountynews.com.
U.S. Food and Drug Administration
February 17, 2012 | 1542 views | Post a comment

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 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.

FULL RECALLED PRODUCT LIST:
Product Name Infants’ TYLENOL Oral Suspension 1oz. Grape
Lot Numbers BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00
UPC Code 300450122308

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.
This voluntary recall is being conducted with the knowledge of the FDA.
 
« Previous Blog Entry (February 13, 2012)
 


Your Opinions and Comments
Be the first to comment on this story!

You must be logged in to post comments:



Other Consumer Updates


 
^Top
  Copyright © 2014 Wilson County News. All rights reserved. Web development by Drewa Designs.
^Top