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Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
McNeil Consumer Healthcare, a division of Johnson & Johnson (J&J), has once again expanded the recall of certain OTC products because of a musty or moldy odor, which has been linked to trace amounts of the chemical 2,4,6 triburomoanisole (TBA).
McNeil Consumer Healthcare, a division of Johnson & Johnson (J&J), has once again expanded the recall of certain OTC products because of a musty or moldy odor, which has been linked to trace amounts of the chemical 2,4,6 triburomoanisole (TBA). The recall was originally announced in January 2010, was extended to five additional product lots in June, and then to a further 21 product lots last week. The full list of recalled products and lots can be found on McNeil’s recall website.
The contamination is believed to stem from the breakdown of a substance applied to wood, which is used to build pallets that transport and store packaging materials. In its latest statement regarding the recall, McNeil explained that it stopped accepting shipments of materials from its suppliers on that type of pallet after the recall was first announced. Since the first recall, however, it has been working with external suppliers to track down shipments involving the wooden pallets and then to tie them to specific lots of manufactured products.
The most recent lots have been added to the recall as a “precautionary measure” after J&J determined that some packaging materials used in them had been shipped and stored on the wooden pallets.
Fortunately, the risk of serious adverse medical events in response to the contamination is remote, according to a statement from J&J; however, the company said that it has received a few reports of gastrointestinal-related events, such as stomach discomfort.
The company has also been subject to heavy criticism since the recall was announced, including a reprimanding warning letter from the US Food and Drug Administration in January.
There may also be further trouble ahead for the pharmaceutical giant regarding a product recall announced in April of certain OTC infants’ and children’s products as a handful of consumers have filed complaints seeking class-action statements. According to reports from Reuters and Bloomberg, the complaints accuse the company of “fraud and racketeering” for not recalling all of its children’s medicines and also for not offering consumers the opportunity to recover out-of-pocket expenses.
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