J&J/McNeil widens a recall of contaminated Tylenol

Pharmaceutical CommercePharmaceutical Commerce - November/December 2009

Early November recall of musty-smelling product is expanded from five to 54 lots; McNeil attributes the problem to packaging storage materials

Smelly product that is making consumers sick is an unusually dramatic product recall, but that is the situation that J&J/McNeil (Fort Washington, PA) finds itself in. Even more unusual is the expansion of the recall, from five lots of Tylenol Arthritis Pain 100 Count bottles (announced on Nov. 6) to 54 lots. The containers are also identifiable by having a red “EZ-Open” cap.

According to a McNeil statement, the recall started when consumers began complaining of “an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea.” The source of the odor is “caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious.”


A query to McNeil went unanswered, but there are several aspects of this incident to consider. The chemical 2,4,6-tribromoanisole is the breakdown product of 2,4,6-tribromophenol, a fungicide used on wood as a preservative. Literature references identify the breakdown product as an unusually strong-smelling contaminant; it is a problem in the wine industry where it sometimes shows up in corks. The toxicity of 2,4,6-tribromophenol is apparently relatively mild—but it is not a heavily studied compound. How the contaminant passed from the transportation pallets to the packaging materials is something of a mystery—it is not common to have the two in direct contact with each other.

McNeil is only now getting over another recent recall, of 20 types of children and infant-formulated liquid Tylenol that occurred in late September. Those products were found to be contaminated with bacteria. The Philadelphia Inquirer has reported that McNeil is in the process of moving production of Tylenol to a new facility that will begin production in January. News outlets reporting the latest recall (and, let’s admit it: Pharmaceutical Commerce) can’t help noting that Tylenol was the victim of one of the most notorious product-contamination cases in recent history, when a small number of bottles on retail shelves were contaminated with cyanide in 1982, resulting in several deaths. The incident led to the introduction of tamper-proof packaging for many consumer products.

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