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About 12,000 units of Infants’ Mylicon Gas Relief Dye Free nonstaining drops that were sold over the counter in 1-ounce bottles and distributed after October 5, 2008, are being recalled voluntarily by the manufacturer because of possible contamination with metal fragments during the manufacturing process. The FDA states that adverse medical events would be expected to be temporary and to resolve without treatment. Lot numbers and instructions for refunds can be found at http://www.mylicon.com. The recall does not affect original Mylicon Gas Relief products or the ½-ounce size of the dye-free drops.
Johnson and Johnson–Merck Consumer Pharmaceuticals Company announces urgent voluntary nationwide recall of Infants’ Mylicon Gas Relief Dye Free drops (simethicone-antigas) non-staining due to possible metal fragments [press release]. Fort Washington, PA: Johnson & Johnson · Merck Consumer Pharmaceuticals Company; Nov 7, 2008. (http://www.fda.gov/oc/po/firmrecalls/johnsonjohnson11_08.html)
Comment
The FDA and the manufacturer do not provide information about the type of metal fragments involved. Therefore, pediatricians will have to reassure families without knowing the contaminant, quantity involved, or side effects to anticipate. The FDA and the manufacturer need to provide full disclosure of information on recalled products so that physicians can provide appropriate patient care.