Pfizer ($PFE) has switched to plastic pallets and speeded up plastic bottle deliveries to minimize the risk of TBA contamination, the culprit in its recent Lipitor recalls. The drug giant has also moved its bottling operations to other locations and appears to be reaping early benefits from its efforts to fight the musty odor that now pervades drug recalls by three manufacturers in the last year.
Wooden pallets and the mold-friendly tropical environs of Puerto Rico are common to the recalls: J&J/McNeil's ($JNJ) recall of 6 million bottles of Tylenol arthritis caplets and the Depomed ($DEPO) recall of diabetes drug Glumetza. The contaminant is the byproduct of a fumigant used on wooden shipping pallets.
A root cause analysis identifies "episodic exposure of the bottles to low levels of TBA (tribromoanisole) as they are shipped or stored," Pfizer says. Its investigators found TBA, a byproduct of the wood fumigant TBP, in the air, insulation and paint of the contractor facility, as well as in cartons, shrink wrapping and plastic bags. They also detected it in wooden pallets, which the contractor had received from a supplier that claimed no TBP treatment.
Pfizer says the bottle supplier has enhanced ventilation at its plant to minimize TBA risk. Although Pfizer doesn't name the contractor, the FDA identifies packager Rexam, of Las Piedras, Puerto Rico, as one of the recalling manufacturers.
- see the recall notice
- here's a Pfizer backgrounder (PDF)