FDA warns Johnson & Johnson (J & J) over their alleged hazardous drugs and kickback bribeshttp://www.businessweek.com/news/2010-01-15/j-j-gets-u-s-fda-warning-on-delayed-report-of-tainted-tylenol.html
Jan. 15 (Bloomberg) -- The U.S. Food and Drug Administration sent a warning letter to Johnson & Johnson, saying the drugmaker waited more than a year to notify regulators after getting complaints that tainted bottles of Tylenol sickened customers.
The medicines may have been tainted by a pesticide and flame retardant applied to wooden shipping pallets, the company said in a statement. New Brunswick, New Jersey-based J&J received about 70 complaints of musty or mildew-like odors in Tylenol caplets as well as reports of nausea, vomiting and diarrhea after use, the FDA said.
“They became aware of the problem in September 2008 and their investigation and report to the agency didn’t occur until about a year later, and we would have expected action to occur sooner than that,” Hirshfield said.
The FDA’s warning letter alleged violations of manufacturing, notification and quality-control rules. It was issued the same day the U.S. Justice Department said J&J paid kickbacks to Omnicare Inc., the largest U.S. pharmacy for nursing home patients, to push prescriptions for its antipsychotic drug Risperdal.