‘Phantom recall’ dogs J&J at congressional hearing
pharmafile | June 1, 2010 | News story | Manufacturing and Production |Â Â Johnson & Johnson, McNeil, Tylenol, manufacturing complianceÂ
Johnson & Johnson subsidiary McNeil Consumer Healthcare initiated a recall of its painkiller Motrin (ibuprofen) last year without informing the US Food and Drug Administration (FDA) there was a problem with the product, it is claimed.
The allegation was made last week by Edolphus Towns, chairman of the Committee on Oversight and Government Reform, during a hearing on J&J’s recall of dozens of liquid Tylenol and children’s medicines last month.
“According to an FDA document, McNeil knew there was a potential problem with one of its Motrin products that was on the market in 2008,” said Towns in his opening address at the hearing. A webcast of the event can be accessed here.
However, “rather than issue a public recall, McNeil allegedly sent contractors out to stores to buy the product back and told the stores ‘not to mention’ a recall,” he continued.
Among the evidence presented at the hearing is a copy of a document prepared by the contractor which instructs staff to purchase all supplies of Motrin IB Caplet 8ct Vial available in stores and “act like a regular customer.”
“There must be no mention of this being a recall of the product!” it continues.
After being confronted by the FDA on the matter McNeil made a public announcement of the recall, according to Towns, who said the matter “warrants further investigation by this committee.”
Colleen Goggins, worldwide chairman of Johnson & Johnson Consumer Group, maintained at the hearing that the contractor had operated outside the terms of its brief and that J&J was unaware of its actions.
Meanwhile, FDA Deputy Director Joshua Sharfstein said the agency was aware of the project, but had been informed that the aim was to identify how widely the Motrin packs had been distributed.
He also said the agency “has had growing concerns about the quality of [McNeil’s] manufacturing process … over the last several years.”
The FDA has inspected the company’s facilities with increasing frequency, with violations found at the Fort Washington facility involved in the latest recall – which remains shut down – as well as a unit in Las Piedras, Puerto Rico.
Problems encountered included bacterial contamination of excipient used in the manufacture of products, particles of acetaminophen, cellulose, nickel and chromium in products, and in one product the possibility of higher than expected doses of Tylenol being delivered.
The FDA believes these violations indicate “a pattern of conduct, including failure to report material information to FDA in a timely manner,” said Sharfstein, who added that the agency is considering additional enforcement measures “which may include seizure, injunction or criminal penalties.”
He also said the agency was planning to change its own approach in these cases, so that lessons learnt from inspections of one facility can guide inspections of another.
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