J&J pulls Simponi injectors on possible dosing defect

Another day, another Johnson & Johnson ($JNJ) recall. The company has now recalled lots of Simponi injection devices because of their potential to deliver a substandard dose of the arthritis treatment. The recalled devices are in the U.S. and Germany, and European officials immediately warned that it could spawn a temporary shortage of Simponi injectors in the region.

Patients can use prefilled Simponi syringes instead, but the recall could undermine public faith in J&J even further. The company has lost more than $900 million in sales from its series of recalls, and it issued three recalls over the past week alone.

The company has taken a series of steps to remedy its manufacturing and quality-control difficulties, which have ranged from chewable Rolaids contaminated with wood particles to musty-smelling Tylenol that sickened some patients. Most of the recalls have originated at McNeil Consumer Healthcare, where noted brands such as Tylenol and Motrin have fallen short. The company has also pulled contact lenses, device parts and prescription drugs.

The Simponi recall stemmed from a manufacturing problem in Switzerland. As Dow Jones reports, many of the affected lots were set aside before hitting the market, but some 395 of the prefilled injectors made it past the wholesale level. European authorities said new injection pens will be available by the end of the month, but regular supplies won't return until May. They're recommending that no new patients start treatment with the pens until the supply issue is resolved.

- check out the EMA's Q&A document (.pdf)
- read the Dow Jones news
- get more from the Wall Street Journal Health Blog
- see the Reuters article

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