FDA reminds, guides on fighting musty odor

Give wooden pallets the sniff test and get certification from suppliers that no halogenated phenolic preservatives have been used in the lumber. That's guidance from the FDA, which also reminds drugmakers that cGMP compliance requires written procedures for sanitation that prevents the contamination of equipment, components and drug products.

Halogenated phenolic preservatives, including the 2,4,6-tribromophenol (TBP) that degrades to the musty 2,4,6-tribromoanisole (TBA) behind the Tylenol, Depomed and Pfizer recalls, can be detected by consumers even at the parts-per-billion level, the regulator says. So you may be able to get a whiff of it while product is still in process.

That's what happened with Pfizer last March at its Freiburg, Germany, plant. Quality inspectors detected the odor in two lots of empty bottles from the Puerto Rican plant of its bottle supplier. They rejected the bottles and notified the supplier. They eventually rejected additional lots of empty bottles.

Nonetheless, the drug giant still got three consumer complaints of the odor in July and joined the bottler in analyzing the Puerto Rican plant, as reported. Shortly thereafter, the drug giant mandated plastic pallets and shifted some bottle production to the supplier's sites in the U.S., says Pfizer spokesman Rick Chambers in an email. At those sites, pallets made of North American lumber are unlikely to have been treated with TBP.

Product filled in bottles made by the supplier prior to changes at its Puerto Rico plant may still be in the supply chain, the company says, so there may yet be additional recalls.

- see the FDA guidance
- here's a Pfizer summary (PDF)