McNeil Consumer Healthcare has voluntarily recalled all available product lots of Tylenol Arthritis Pain Caplet 100 count bottles. In November 2009, five lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the presence of a chemical believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.
But consumers beware: this phenomenon is not unusual. Packaging not only acts as a barrier against contamination but it is also a source of contamination. In most cases, it is not a question of whether packaging components will leach into a product, it’s a question of how much. And pharmaceutical products are not immune to leaching. As a result, regulatory agencies collect information in order to document the safety margins of these food and drug “leachables”. Still, there is no set guideline among the governmental agencies. For instance, last year, the Canadian government banned the use of BPA in baby bottles as a precautionary measure against the risk that its presence could cause endocrine disruption in children--the FDA and other foreign agencies dispute the Canadian’s safety margins.
Still, scientists are trying to come up with a packaging material that prevents leaching of products. While a fool proof solution is yet to be found, the most successful anti-leaching products are available, at a price--the containers sometime cost several times the price of the components they replace.
In the meantime, pharmaceutical companies like McNeil Consumer Healthcare will continue to voluntarily recall their contaminated products. For all contaminated products, the consumer should stop using the product and contact the manufacturer for instructions on a refund or replacement.

Labels: drugs, FDA, products, recall