J&J’s latest recall put down to new factor
pharmafile | August 19, 2011 | News story | Manufacturing and Production |Â Â J&J, JJ, Tylenol, recallsÂ
Yet another Johnson & Johnson recall has been announced, but this time the perpetrator doesn’t feature among the ‘usual suspects’.
J&J’s McNeil Consumer Healthcare unit has called back 2.5 million packs of its Tylenol Cold Multi-Symptom Nighttime rapid release gelcaps in the USA and Puerto Rico because of higher than usual levels of a compound known as chlorpheniramine ammonio acetate, or CPAA.
To date, most of J&J recalls have been the result of contamination with solid particles, sterility failures and contamination with chemicals that leeched into drug bottles in contact with chemically-treated wooden pallets, as well as variations in product potency.
J&J said the recall was being undertaken at the wholesale and retail level, but not to the consumer level as “the risk of any adverse health effects related to the reason for the recall is unlikely”.
CPAA is a compound formed from the combination of two product ingredients found in the Tylenol brand, said J&J, adding that “certain levels are expected in the product”.
J&J has now ordered 17 recalls of over-the-counter products, including more than 10 involving its Tylenol range, since the start of 2010. The recalls mainly involve products made at the company’s troubled manufacturing facilities in Fort Washington in Philadelphia and Las Piedras in Puerto Rico, and cost the company $900 million in lost sales in 2010 alone.
The latest recall involves products made at Fort Washington before production there was suspended in April 2010, as well as at the Las Piedras site which remains in operation.
Earlier this year J&J was placed under a consent decree by the US FDA, forcing the company to adhere to a strict timetable in bringing its manufacturing operations back up to code or face financial penalties.
Phil Taylor
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