The December 18 recall of six million bottles of Tylenol arthritis caplets follows by six weeks an early-November recall of just five lots of the drug, which was announced by Johnson & Johnson's McNeil Consumer Healthcare on the Tylenol Internet site. An additional ten days went by, until December 28, before the FDA issued its more widely seen and accessible medical alert for the contaminated pills.
The all-out recall encompasses arthritis pain reliever produced over the past three years, stemming from contamination likely caused by the breakdown of a chemical treatment used on wooden pallets. The chemical contaminant 2,4,6-tribromoanisole, reportedly not well studied, is believed to have seeped into empty medication bottles. The contamination resulted in a musty odor and cases of nausea, vomiting and diarrhea.
ABC World News suggests that the Tylenol incident is proof that the U.S. drug recall system is broken. The FDA, and not manufacturers, should have the power to issue drug recalls, the news organization says.
Regarding the ten-day delay between the all-out Tylenol recall and the FDA medical alert, the FDA says it is "looking into the case," reports ABC.
- here's the FDA medical alert post [1]
- see the J&J announcement [2]
- watch the ABC World News report [3]
Links:
[1] http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm195704.htm
[2] http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tar_recall.inc
[3] http://abcnews.go.com/search?searchtext=tylenol%20recall