Glumetza Recall Blamed on Treated Wood Pallets

The pallet mold inhibiting chemical TBA is back in the news. Earlier this year it was implicated in a large Tylenol recall, where product was found to have a musty smell that Johnson & Johnson suggested had originated in wood pallets that had been treated with an unsanctioned pallet mold control chemical called “tribromophenol” or TBP, which is used in some countries as a preservative on wooden pallets. After application, the product can break down into the problematic 2,4,6-tribromoanisole or TBA, which can result in the odor.

In mid-June, the McNeil Consumer Healthcare division of Johnson & Johnson expanded its recall for a second time. Now Depomed Inc. has also initiated a product recall due to TBA.

Glumetza is a diabetes drug sold by Depomed Inc. The TBA was detected in the drug’s bottle. The recall is being carried out at the wholesale level, and involves 52 lots of Glumetza 500mg tablets. Depomed indicated that the contamination may have originated with pallets previously used to transport Glumetza product bottles to its contract manufacturer in Puerto Rico.

The use of tribromophenol is unsanctioned in much of the world but is still approved in some South American countries.

While mold has long been a problem in hot humid climates, it has received increased attention in recent years. To some degree, the mold problem for pallets has been exasperated by the introduction of heat treatment requirements for wood products, including pallets, being shipped internationally. The heat treatment requirement of ISPM-15 was put into place to prevent the movement of wood bone pests internationally. While killing pests, the heat treatment process also draws moisture in the wood closer to the surface, which creates a better environment for mold to take hold.

According to a report in Pallet Profile Weekly, companies in the U.S. are becoming increasingly guarded about using any kind of mold prevention wash on pallets in the wake of the Johnson & Johnson recall, even products typically used in food preparation environments such as soap and bleach, in the absence of FDA approval.

Two pallet mold treatments currently being offered in the U.S. include X-Mold from X-M Industries and PQ-80 from ISK Biocides.

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