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HARTFORD, CT - November 12 - The Department of Consumer Protection is advising consumers about a recall of an infant medication used to treat gas. Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) 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 # 71683791111-1 Lot # SMF007 Exp 09/10 Product Infants' Mylicon® Gas Relief Dye Free Non-Staining Drops 1 oz.
Product Code # 71683791111-1 Lot # SMF008 Exp 09/10 Product 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.
Consumers who purchased Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining included in this recall 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.
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 frequently caused by air swallowing or by certain formulas or foods.
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).
The manufacturer has instructed retailers and wholesalers to return their inventories.
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