Safety Alerts & Recalls

What does this mean?

Although the potential for serious medical events is low, the company is issuing this recall as a precaution. If any medical events were to occur, most are expected to be temporary and go away without medical treatment. If you have given the product to your infant and are concerned, you should contact your health care provider immediately.

If you have purchased Infants' MYLICON GAS RELIEF DYE FREE drops non-staining, look at your bottle or packaging to see if you can find a lot number. You can find the lot number on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle. If the lot number matches SMF007 or SMF008 you 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.

Nationwide Recall of Two Lots of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)

Johnson & Johnson/Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling two lot numbers of Infants' MYLICON GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were sold after October 5, 2008. 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 often caused by air swallowing or by certain formulas or foods. The company is issuing this recall after determining that some bottles in these two lot numbers could contain metal fragments.

The following Product Numbers and Lot Number are involved in this recall: Infants' Mylicon Gas Relief Dye Free Non-Staining Drops 1 oz, Product Number 71683791111-1, Lot numbers SMF007 and SMF008 both with expiration dates of September 2010.

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).

For more information please visit: more information here

Source: FDA
Publication Date: 2008-11-12
Last Updated: 2009-12-05

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