Approximately 12,000 plastic 1 ounce bottles of Infants’ Mylicon Gas Relief Dye-Free Drops (simethicone-antigas) sold since October 5, 2008 have been recalled after it was discovered that some of the bottles could contain metal fragments.
Mylicon gas relief drops are manufactured by Johnson & Johnson-Merck Consumer Pharmaceuticals Co., which is a joint venture between Merck and Johnson & Johnson to market non-prescription products derived from Merck prescription medications.
Infants’ Mylicon is an over-the-counter anti-gas medicine, which is used to relieve the discomfort commonly caused by infants swallowing air or from certain formulas and foods.
Consumers have been urged to immediately stop using any 1 oz plastic bottles of dye-free Mylicon infant drops with lot numbers SMF007 or SMF008, which can be found on the bottom of the box the product came in, or on the lower left side of the sticker on the bottle. The recall applies to products labeled “Infants Mylicon Gas Relief Dye Free Non-Staining Drops 1 oz.” with expiration dates of 09/10.
The Mylicon gas relief drops recall was issued as a precaution because some bottles could contain metal fragments that were generated during the manufacturing process.
In a press release announcing the Mylicon recall, Johnson & Johnson indicated that “the potential for serious medical events is low”, and that if any problems do occur, it is expected that they will be temporary and resolve without medical treatment. However, parents who have given the product to their infant should contact their healthcare provider immediately if they are concerned.
The recall only applies to 1 ounce dye-free Mylicon gas relief drops. Original Infants’ Mylicon Gas Relief products, which are available in 1/2 oz. and 1 oz. sizes, as well as Infants’ Mylicon Gas Relief Dye Free drops non-staining sold in 1/2 oz. sizes, have not been recalled and there is no indication that they may contain metal fragments.