Johnson & Johnson - Merck Consumer Pharmaceuticals Company has recalled 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. 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 company is initiating the recall in consultation with the U.S. Food and Drug Administration (FDA). Although the company claims the potential for serious medical events is low, they are implementing the recall to the consumer level as a precaution after determining that some bottles could include metal fragments from the manufacturing process.
According to a joint press release issued by Johnson & Johnson - Merck, any medical events that might occur as a result are expected to be temporary and resolve without medical treatment. However, the absence of manufacturing controls that would have prevented the contamination in the first place, may leave consumers justifiably doubtful of the risk assessment.
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When any foreign contaminant is ingested by an infant, there may be risk of injury. Parents who have given the product to their infant and are concerned should contact their health care provider immediately. If this defective product was administered to your child and your child suffered medical complications or injury as a result, you may be entitled to claim compensation from those responsible. An experienced medical injury lawyer can explain your options.
The two lots of Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:
| Product Code # |
Lot # |
Expiration |
Product |
| 71683791111-1 |
SMF007 |
09/2010 |
Infants' Mylicon® Gas Relief Dye Free Non-Staining Drops 1 oz. |
| 71683791111-1 |
SMF008 |
09/2010 |
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.
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.