Mylicon drops for infants recalled

Infants’ Mylicon Gas Relief Dye Free Non-Staining Drops have been recalled due to the potential for contamination with metal fragments generated during the manufacturing process. The simethicone drops are sold in one-ounce plastic bottles with one of two lot numbers: SMF007 and SMF008.  The lot numbers are located either on the bottom of the box containing the product or on the lower left side of the label on the bottle.

The bottles were distributed throughout the U.S. after Oct. 5. The recall does not affect any Original Infants’ Mylicon Gas Relief products (1/2 oz- or 1-oz size) or the half-oz size of Infants’ Mylicon Gas Relief Dye Free Non-Staining Drops.

The manufacturer, Johnson & Johnson Merck Consumer Pharmaceuticals, has said the potential for adverse events is low, and those that do occur are expected to be temporary and resolve without complication. Parents who have given the product to their infant should immediately stop using the product and are advised to contact their health care provider immediately.  The company can be contacted by calling 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00 p.m. EST) or via the internet at www.mylicon.com. 

via FDA, November 7, 2008

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