Last December, the producer of Tylenol reported a recall due to what was described as an unusual odor. Since then, the recall has been extended to include additional products most of which were produced at a factory in Puerto Rico. The recall now covers more than 50 million consumer packages. Some illnesses are alleged.
Tylenol’s manufacturer issued a statement on December 18 stating: “The uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of the 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.”
The pallets in question are believed to have originated in the Dominican Republic however; it is proving to be difficult to trace their exact origin. To complicate matters, the Dominican Republic shares the island of Hispaniola with Haiti and has suffered significant infrastructure disruption as a result of the recent earthquake.
What might this mean to you? Keep in mind that wooden pallets are used and re-used throughout the industry. The problem was identified following a spike in consumer complaints. The pallets bearing early shipments of off-odor products have had plenty of time to work their way to your dock! Once in your warehouse, they may cause issues with product stored on or adjacent to affected pallets.
If your product line includes FDA Regulated Food, Drug, Cosmetic or Medical Device items you should be especially concerned. The FDA’s position is bluntly stated in an official warning letter to the Tylenol Manufacturer.
The FDA Warning Letter cites Tylenol’s producer for failure to submit Field Action Reports (FARs) to the FDA within three days. Had the product been a food, the allowed time would have been 24 hours effective when the Reportable Food Registry (RFR) regulations went into effect on September 8, 2009. The RFR uses FDA’s new electronic portal.
Be sure your drivers, warehousemen and dock workers are alert to this problem and equipped to take prompt decisive action.
