Johnson & Johnson 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 devices. As an alternative, patients are being advised to use prefilled syringes of Simponi.
The Simponi recall is the latest in a series at J&J due to manufacturing-quality lapses, which have hurt sales and damaged the company’s reputation. The biggest have involved J&J’s over-the-counter medicinesincluding Tylenol. But recalls also have been issued for other J&J products, including certain pharmaceutical and device products this month.
Simponi, which went on sale in 2009, is approved to treat rheumatoid arthritis and other inflammatory conditions. It’s typically injected monthly, through prefilled syringes or pre-filled “pens,” 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 quarantined the bulk of the affected lots, with the recall covering those that got past the wholesale level — about 230 Simponi pens in Germany and 165 pens in the U.S.
The European Medicines Agency said Friday that only certain Simponi pens were being recalled and that other pens 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 start treatment with the pens until the supply problems are resolved.
Though J&J manufacturers the Simponi pens in Europe, Merck & Co. markets the product in Europe under a partnership with J&J, while J&J handles U.S. marketing. A Merck spokesman wasn’t immediately available.
J&J shares rose 24 cents, to $61.03, and Merck fell 8 cents, to $33.02, in early afternoon trading.
