J&J expanded its nation-wide recall of Tylenol Arthritis Pain (100ct bottle with EZ-Open Cap) today from 5 lots to 54 lots.  It appears consumers noticed a musty off-odor and some became ill with gastrointestinal distress.  This product is contaminated with 2,4,6-tribromoanisole, a degradant of a phenolic chemical used as either a fungicide in the preservation of wood, or as a fire retardant in plastics.  This caps a year of unrelated incidents each challenging Tylenol's heritage of safety.

Tylenol Arthritis Pain with an EZ-Open closure is used by elderly arthritics who have difficulty opening pill bottles.  As noted by the manufacturer in its recall notice [http://www.fda.gov/Safety/Recalls/ucm195690.htm] the complete toxicology of this degradant is poorly described.  Fortunately, the acute toxicity of this group of compounds seems minimal.  Nevertheless, the elderly as a sub-population often exhibit declining liver and kidney function and are less capable of detoxifying organic contaminants.

J&J claims the source of the contamination is 2,4,6-tribromophenol, a fungicide found in treated wood pallets.  Ambient fungus can transform it to its anisole degradant.  This degradant is fairly volatile and over time can accumulate on surfaces such as plastics.  The first quality investigation should prove that the supplier of the plastic bottles did not unintentionally contaminate the bottle resin itself since resin polymers can be formulated into fire resistant "capped" versions using brominated anisoles.  Second, and more likely, is that the cleaning procedures in the plant used chlorine solutions on wooden pallets that accelerated the conversation of the fungicide to its degradant.  The fact that J&J is moving to another manufacturing facility as a result of this incident suggests a problem relating to cleaning procedures and/or wider plant surface contamination.  Plastic pallets, although more expensive, are a good substitute for wood and allow cleaning with conventional bleach solutions.  Clearly the manufacturing process from raw material specs, to storage conditions for packaging, to cleaning and decontamination need review.

[Dr. Riker is a former Associate Director, Personal Healthcare at Procter & Gamble, and the last Vice President of R&D & CSO, including Quality Control, at Chattem]