J&J recalls more products for contamination

The unusual case of contamination that caused Johnson & Johnson to recall several lots of Tylenol Arthritis Pain caplets is more widespread than feared, affecting a number of the drugmaker's other over-the-counter (OTC) products.

The drugmaker's McNeil Consumer Healthcare unit initiated the recall last month after complaints by consumers of a musty smell and mouldy taste in the medicines as well as cases of gastrointestinal side effects.

The latest alert - issued on January 15 - notes that J&J has broadened the recall to include other products in the Tylenol range as well as allergy treatment Benadryl, the pain reliever Motrin (ibuprofen), St. Joseph brand aspirin, Simply Sleep and Rolaids for heartburn.

The recall also now extends outside the USA to include product shipped to the United Arab Emirates, Fiji and the Americas.

FDA warning letter

To add to J&J's woes, the expanded recall - which now takes in a whopping 53 million individual products - is accompanied by a ticking off by the US Food and Drug Administration (FDA) for not responding quickly enough to the problem.

The contamination was caused by a chemical called 2, 4, 6,-tribromoanisole (TBA), itself a degradation product of a flame retardant (2,4,6, tribromophenol or TBP) used to treat wooden pallets used for transporting packaging materials and finished products.

It is thought that as a volatile compound, TBP was able to leach through the primary and secondary product packaging - cardboard and/or plastic bottles - and into the contents. This is an unusual case because where this form of leached contamination is encountered the culprit is usually the primary packaging itself.

A letter sent to J&J by the FDA on January 8 censures the firm's quality control staff for not identifying the contamination quickly enough - despite complains stretching back to September 2008 - and delaying a recall for several months once it was identified.

The agency is also concerned that J&J started off with a limited recall before widening it to include all the affected product lines.

"Corporate management has the responsibility to ensure the quality, safety, and integrity of its products," said the FDA in its warning letter.

"Neither upper management at J&J nor at McNeil Consumer Healthcare assured timely investigation and resolution of the issues," it continues.


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