Treated Wooden Pallets Cause of Massive Odor-Related Recall

March 29, 2010 – McNeil Consumer Healthcare has traced the source of a musty odor on certain over-the-counter products back to wooden pallets treated with a halogenated phenolic preservative called 2,4,6-tribromophenol (TBP). Because pallets are used in the dietary supplement industry, the International Aloe Science Council (IASC) is bringing this issue to members’ attention.

While rarely used in many parts of the world, including the U.S., TBP treatment of wood continues in some regions that supply wood to the US and other countries. Certain fungi can convert TBP to the halogenated anisole compound 2, 4, 6-tribromoanisole (TBA). This compound produces a strong musty odor and is prone to volatilize and adsorb onto articles stored near the TBA source. According to a question and answer document recently released by the Food and Drug Administration (FDA), because of their volatility, it appears that even minute levels of halogenated anisole compounds can adversely affect a large quantity of product in a single contamination incident.

According to FDA, currently available data indicate that serious adverse health effects have not resulted from ingestion of drugs or foods contaminated with halogenated anisole compounds at the levels of contamination that have been reported.

In the Q&A document, FDA recommends that manufacturers and distributors take precautions to prevent the use of wood products treated with or exposed to a halogenated phenolic preservative anywhere in supply chain. This includes all facilities that manufacture, hold, or distribute drug products, components, or packaging materials. FDA recommends that manufacturers not store drug products, components, or packaging materials near wood or wood-derived storage materials unless there is assurance that the wood material has not been treated with a halogenated phenolic preservative.

FDA further recommends that manufacturers establish agreements and request certification from suppliers to provide assurance that halogenated phenolic preservatives are not present. Manufacturers should also be vigilant to the characteristic odor of the offending compounds so they can intervene before product is contaminated or further distributed.

For more information, see questions five through ten in the “Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Buildings and Facilities”: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm192869.htm#7.

More information is also available in McNeil’s Feb. 5 response to the FDA Warning Letter: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm192869.htm.