This is really weird.
By Peter Loftus, Of DOW JONES NEWSWIRES
Johnson & Johnson (JNJ) has recalled at least 395 injection devices containing rheumatoid-arthritis drug Simponi in the U.S. and Germany, due to a potential defect that could result in an insufficient dose of the drug.
European health authorities warned Friday that the manufacturing snafu could cause a temporary shortage of the Simponi injector devices. As an alternative, patients are being advised to use prefilled syringes of Simponi.
The Simponi recall is the latest in a series of product recalls at J&J due to manufacturing-quality lapses, which have hurt sales and damaged the company's reputation. The biggest impact has been on J&J's over-the-counter medicine brands including Tylenol. But recalls also have been issued for other J&J products, including certain pharmaceutical and device products earlier this month.
Simponi, which went on sale in 2009, is approved to treat rheumatoid arthritis and other inflammatory conditions. It's typically injected monthly, either through prefilled syringes or pre-filled "pens," which are devices that allow patients to press a button to deliver the dose.
J&J recently identified a manufacturing problem at a plant in Switzerland that could result in an incomplete dose of the drug delivered by the pens, said spokesman Brian Kenney. The problem was discovered in routine quality testing.
J&J was able to quarantine the bulk of the affected lots, but some got past the wholesale level, which J&J is now recalling. The recall affects about 230 Simponi pens in Germany and 165 pens in the U.S. that were distributed beyond the wholesale level.
The European Medicines Agency said Friday that only certain Simponi pens were being recalled, and that other pens currently on the market aren't affected and should continue to be used.
J&J will start to make new prefilled pens of Simponi available by the end of February, the EMA said, but not all European countries will have regular supplies until May. The EMA recommended no new patients should start treatment with the pens until the supply problems