Mylicon Recall

For those of you who have and use Mylicon, please note the following recall information.

JOHNSON & 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
Fort Washington, PA (November 10, 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.

For more information, visit the site: http://www.mylicon.com/page.jhtml?id=mylicon/press_release.inc