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SimePed FDA Alerts

The FDA Alert(s) below may be specifically about SimePed or relate to a group or class of drugs which include SimePed (simethicone).

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for simethicone

Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)

Nov 12, 2008

Audience: Consumers, pediatricians, other healthcare professionals

[Posted 11/12/2008] Johnson & Johnson, Merck Consumer Pharmaceuticals Company and FDA notified consumers and healthcare professionals of a voluntary recall of Infants' Mylicon Gas Relief Dye Free Drops ( Lot No. SMF007 and SMF008) sold in 1 oz plastic bottles that were distributed after October 5, 2008, nationwide. The product was recalled because some bottles could include metal fragments that were generated during the manufacturing process. Parents who have given the product to their infant and are concerned should contact their healthcare professional.

[November 07, 2008 - Press Release - Johnson & Johnson • Merck Consumer Pharmaceuticals Company]

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