The total product recall is an expansion of an earlier voluntary recall. In November, the drug manufacturer recalled five lots of the medication due to consumer reports of a moldy, musty or mildew-like odor associated with nausea, stomach pain, vomiting and diarrhea.
According to a statement issued by McNeil, the odor is caused by a chemical called 2,4,6-tribromoanisole (TBA), the source of which “is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.”
The “chemical used to treat wooden pallets” McNeil refers to may be the fungicide 2,4,6-tribromophenol, which can be converted into TBA by strains of the xerophilic fungus Paecilomyces variotii, according to the Journal of Agricultural and Food Chemistry.
TBA has been identified as one of the chemical compounds responsible for “cork taint,” a moldy or musty smell that contaminates wine. For years, the wine and cork industries have grappled with controlling 2,4,6-trichloroanisole (TCA), a compound related to TBA and most often associated with cork taint.
According to a group of grape growers, wine merchants and restaurateurs known as Professional Friends of Wine, cork taint has caused about $10 billion in damages worldwide to the wine industry.
Chemicals other than fungicides as well as a wide range of wooden materials (including, but not limited to, wood packaging material) have been implicated in the formation of TCA and TBA. The wine-connoisseur group says molds capable of converting chemicals into TCA or TBA may be present in raw materials or in wooden walls, stairs, pallets and boxes. The organization also identifies chlorine bleach (used in cork processing and as a general disinfectant in facilities) as one of the chemicals that can be degraded by fungi and therefore converted into TCA or TBA.
McNeil says all of the conditions reported by consumers were temporary and not serious.