J&J expands recall of ‘musty’ products
pharmafile | June 18, 2010 | News story | Manufacturing and Production |Â Â Johnson & Johnson, manufacturing complianceÂ
Johnson & Johnson’s manufacturing troubles continues to build with yet another recall announced this week, this time for additional lots of its Benadryl and Tylenol products that had inadvertently been omitted from a previous recall.
The latest action covers five lots of Benadryl Allergy Ultratab Tablets in 100-count bottles and Extra Strength Tylenol Rapid Release Gels in 50-count bottles which were distributed by the firm’s McNeil Consumer Healthcare subsidiary in the US, Puerto Rico, Bermuda and Trinidad and Tobago.
The “follow-up” recall is related to one first undertaken in November 2009 – and expanded in December 2009 and January 2010 – in which various products were found to be affected by a musty odour and mouldy taste, eventually attributed to a chemical leaching into the products from wooden pallets used during their storage.
The contamination was caused by a chemical called 2, 4, 6,-tribromoanisole (TBA), a degradation product of a flame retardant (2,4,6, tribromophenol or TBP) used to treat the pallets. Customer complaints about the musty odour were received as far back as 2008, according to the FDA.
The first recall covered around 53 million products distributed in the US, United Arab Emirates, Fiji and various other markets in the Americas. It is not clear how many additional product units are covered in the latest expansion of the recall.
J&J insists there is no evidence of any serious harm from the products. “Since January, McNeil Consumer Healthcare has continued to analyse and evaluate TBA and has shared that information with the FDA,” said the company in a statement. “This further analysis confirms that the risk of serious adverse medical events is remote.”
In addition to the recalls because of TBA contamination, J&J is also in the midst of a major recall of around 50 over-the-counter children’s medicines because of quality and safety issues which eventually led to the temporary closure of the company’s manufacturing facility in Forth Worth, Pennsylvania.
The serial recalls and warnings from the US Food and Drug Administration prompted a Congressional investigation into the manufacturing problems at J&J, while the FDA has also referred the case for review by its Office of Criminal Investigations.
Aside from the quality control issues raised in the probe, there have also been claims that J&J initiated a phantom recall of one of its products (Motrin) – getting contractors to buy up the affected product as part of a test purchasing programme – in order to avoid having to announce a formal recall.
Last week, the Congressional committee overseeing the investigation said it was quizzing the contractors involved in the affair, including a product retrieval specialist company called Inmar.
J&J has insisted it knew nothing about the actions of the contractors, although the Wall Street Journal says it has seen internal emails indicating some company officials were aware of the buyback effort.
Phil Taylor
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