• Skip to main content
  • Skip to primary sidebar

An Inconvenient Truth: This Is a Woman

Don’t Get Angry, Get Active!

Hide Search

Urgent Voluntary Nationwide Recall Of Infants’ Mylicon Gas Relief Dye Free Drops

H. Sandra Chevalier-Batik · November 12, 2008 ·

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Johnson and Johnson–Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants’ Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments

Media Contact:

Marc Boston

215-273-7649 (office)

215-429-7034 (mobile)

Bonnie Jacobs

215-273-8994  (office)

856-912-9965 (mobile)

FOR IMMEDIATE RELEASE — Fort Washington, PA (November 7, 2008) – Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants’ MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

The two lots of Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:

Product

Code #

Lot # Exp Product
71683791111-1 SMF007 09/10 Infants’ Mylicon® Gas Relief Dye Free Non-Staining Drops 1 oz.
71683791111-1 SMF008 09/10 Infants’ Mylicon® Gas Relief Dye Free Non-Staining Drops 1 oz.

Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

Consumers who purchased Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product and contact the company at 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00 p.m. EST) or via the internet at www.mylicon.com for instructions regarding how to dispose of the product and request a replacement or refund.

Infants’ MYLICON® drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.

The recall does not affect any Original Infants’ MYLICON® GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining (1/2 oz. size).

The manufacturer has instructed retailers and wholesalers to return their inventories.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s 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 FDA form 3500 available at:

www.fda.gov/MedWatch/getforms.htm.

Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

Fax: 1-800-FDA-0178

Share

Filed Under: Product Recall Tagged With: adverse event, anti-gas medicine, FDA, FDA Press Release, infant gas, Infants, Johnson & Johnson, Merck Consumer Pharmaceuticals Company, Pediatrics, Product Recall, retail stores

Primary Sidebar

Categories

  • Attention-Deficit/Hyperactivity Disorder Medications
  • Big Pharma Watch
  • Biotech Industry
  • Birth Control
  • Breast Cancer
  • cáncer de cuello uterino
  • Cancer Research
  • Cervarix
  • Cervical Cancer
  • Clinical Trials
  • Diabetes
  • Domestic Violence
  • Drug Approvals
  • Emotional Health
  • FDA
  • FDA Black Box Warning
  • FDA Clinical Trials
  • FDA Failure To Protect
  • FDA Product Recall
  • Follow The Money
  • Gardasil
  • Gardasil®
  • Gender Bias
  • Gender Politics
  • genital warts
  • Guillain-Barre Syndrome
  • Hormone Cycle
  • HPV Infection
  • HPV Vaccine
  • HRT
  • HRT Side Effects
  • Influenza A Virus H1N1 Strain
  • Mammograms
  • Mandatory HPV Vaccination Policies
  • Medical Technology
  • Menopause
  • MERCK Watch
  • MMR vaccine
  • National Vaccine Injury Compensation Program
  • PAP Test
  • Prescription Drug Side Effects
  • Proactive Nutrition
  • Product Recall
  • Reproductive Health
  • Sexual Dysfunction
  • Sleep Loss
  • STD Infection
  • Stroke
  • Take Action!
  • Uncategorized
  • Unwanted Pregnancy
  • Vaccination Policy
  • VAERS
  • vaginal yeast infection
  • Virginity
  • Weight Gain
  • Women's Health
  • Women's Rights
  • Work Place Issues
  • World Health Organization
  • Yeast Infection
  • Your Body/Your Self

Archives

  • February 2010
  • October 2009
  • September 2009
  • August 2009
  • July 2009
  • June 2009
  • May 2009
  • April 2009
  • March 2009
  • February 2009
  • January 2009
  • December 2008
  • November 2008
  • October 2008
  • September 2008
  • August 2008
  • July 2008
  • June 2008
  • May 2008
  • April 2008
  • March 2008
  • February 2008
  • January 2008
  • December 2007
  • October 2007
  • September 2007
  • August 2007
  • July 2007
  • May 2007
  • April 2007
  • March 2007
  • February 2007
  • January 2007
  • December 2006
  • November 2006
  • October 2006
  • September 2006
  • August 2006
  • July 2006
  • June 2006
  • May 2006
  • March 2006
  • September 2005
  • June 2005
  • May 2005
  • December 2004
April 2025
S M T W T F S
 12345
6789101112
13141516171819
20212223242526
27282930  
« Feb    

Breast Cancer

  • Cancer Advocacy

Health Advocacy

  • Women’s Universal Health Initiative

Syndication

  • FDA MedWatch

Tags

Big Pharma Watch Birth Control Breast Cancer Cancer Cancer Research CDC Cervarix Cervical Cancer Children's Health Exploitive Behavior FDA FDA Approvals FDA Clinical Trials FDA Failure To Protect FDA Press Release Follow The Money Gardasil Gardasil Adverse Event Gardasil® GlaxoSmithKline GlaxoSmithKline Cervarix Gynecology H1N1 "swine flu" virus H1N1 pandemic influenza preparedness efforts Health Advisory HPV HPV-Associated Cervical Cancer HPV-Vaccination HPV Infection HPV Vaccine HRT Human Papillomavirus (HPV) Infection Merck PAP SMEAR PAP Test Proactive Nutrition Questionable Medicine STD Infection STD Vaccination swine flu vaccine Swine flu vaccine production Take Action! Uncategorized Woman’s Health Your Body/Your Self

Copyright © 2010-2025 Hands On WordPress · All Rights Reserved