Tylenol maker McNeil Consumer Healthcare says it has confirmed the odor-causing culprit and implemented fixes to its QA and supply chain systems in the wake of an arthritis medication recall late last year that mushroomed to a 50-million unit recall encompassing several consumer-leading brand medications. The company reported back to the FDA in an early-February letter from president Peter Luther. The letter was just posted to the FDA web site, thanks to a New York Times freedom of information request.
McNeil, a unit of Johnson & Johnson, hired a forensics lab to confirm its suspicion that the breakdown of a preservative used on wooden pallets was the culprit behind an odor in the products and packaging that sickened some drug takers. The specialized lab, whose name is redacted in the letter, performs part-per-trillion-level testing via a process that can handle just eight samples per day, according to the letter.
As a corrective and preventive action, McNeil says it now requires suppliers to ship drug ingredients and packaging components on heat-treated pallets, rather than those treated with the preservative. McNeil says also that it is destroying on-hand components that had been shipped on pallets that the company could not confirm to be preservative-free.
The company also has named Veronica Cruz VP for quality assurance, moving her from the quality operations VP spot at J&J's global pharma supply group. Additional fixes in the wake of the incident include changes to the company's field alert reporting and investigation procedures, as well as complaint-review and -handling procedures.