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Subject:
From:
Marie Davis <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Thu, 13 Nov 2008 10:22:41 -0800
Content-Type:
text/plain
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"The recall does not affect any Original Infants' MYLICONŽ GAS RELIEF 
products (1/2 oz. or 1 oz. size) or Infants' MYLICONŽ GAS RELIEF DYE FREE 
drops non-staining (1/2 oz. size). "


JOHNSON & JOHNSON . MERCK CONSUMER PHARMACEUTICALS COMPANY ANNOUNCES URGENT 
VOLUNTARY NATIONWIDE RECALL OF INFANTS' MYLICONŽ GAS RELIEF DYE FREE DROPS 
(SIMETHICONE-ANTIGAS) NON-STAINING DUE TO POSSIBLE METAL FRAGMENTS

Fort Washington, PA (November 10, 2008) - Johnson & Johnson . Merck Consumer 
Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 
12,000 units of Infants' MYLICONŽ 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' MYLICONŽ 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' MYLICONŽ Gas Relief Dye Free Non-Staining Drops 1 oz.

      71683791111-1
     SMF008
     09/10
     Infants' MYLICONŽ 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' MYLICONŽ 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' MYLICONŽ 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' MYLICONŽ GAS RELIEF 
products (1/2 oz. or 1 oz. size) or Infants' MYLICONŽ 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.

             ***********************************************

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