The U.S. Food and Drug Administration has announced the recall of 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 manufacturer, Johnson & Johnson - Merck Consumer Pharmaceuticals Company, reports that some bottles could include metal fragments that were generated during the manufacturing process.

The recall includes the following two lots of Mylicon Gas Relief Dye Free drops non-staining 1 oz bottles:

Lots #: SMF007 and SMF008
Product Code: 71683791111-1
Expiration Date: 09/10

Look for this information on the bottom of the box and also on the lower left side of the sticker on the bottle.

If you have the recalled product, you area advised to stop using it immediately and contact the company by calling 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00 p.m. EST) or by visiting their Website for instructions on 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. This 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).

If you have given this product to your infant and are concerned, contact your doctor immediately. Any adverse reactions or other problems should be reported to the FDA's MedWatch Adverse Event Reporting program.