The FDA discovery in mid-April of high API concentrations, substandard inactive ingredients and particle contamination in Children's Tylenol and other products has led to the shutdown of J&J's McNeil Consumer Healthcare manufacturing facility in Fort Washington, PA. The shutdown and related product recall marks a continuing slide by Johnson & Johnson to GMP-violation depths formerly reserved for offshore generics makers.
The recall encompasses all lots of certain over-the-counter children's and infants' liquid products distributed in the U.S, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Kuwait, Panama, Puerto Rico and Trinidad & Tobago--"a vast portion of the children's medicine market," says the Washington Post. It involves hundreds of thousands of bottles that now sit in homes and on store shelves.
The FDA says in the Post report that the plant's manufacturing process was not in control and that "this does go back in time."
The recall follows two others at the end of March--one stemming from defective Tylenol pill bottles and the other from label issues--as well as the late 2009 musty-odor recall that sickened Tylenol arthritis medication users. The musty-odor recall elicited a warning letter citing the FDA's concerns over the "thoroughness and timeliness" of the drugmaker's response once it learned of consumer adverse reactions.
McNeil says it is conducting a "comprehensive quality assessment across its manufacturing operations and has identified corrective actions," which are not named in its recall notice. The drugmaker in March appointed former J&J global pharma quality ops exec Veronica Cruz as VP for quality assurance, following the musty-odor recall.