Simponi (golimumab) is a TNF-alpha blocker.
Simponi, typically injected monthly alone or in combination with methotrexate, was approved by the FDA on 24 April 2009 for the treatment of moderate to severe rheumatoid arthritis, active psoriatic arthritis (alone or with methotrexate), and active ankylosing spondylitis.
Reportedly, J&J has recently discovered a manufacturing problem during routine quality testing at a plant in Switzerland that can prevent the full dose from being delivered by the pens.
In a statement, the European Medicines Agency said only certain lots of Simponi pens were being recalled, and others currently on the market are not affected and can be used.
The recall is the fourth in recent weeks, and is preceded by the pull-out of cracked syringes of Invega Sustenna for schizophrenia, Secure Strap hernia devices with faulty packaging, and discolored vials of Dermabond wound treatments.
The company is reported to have retracted 40 consumer products last year in addition to contact lenses and artificial hips.
J&J manufacturers the Simponi pens in Europe, Merck markets it in Europe under a partnership with J&J, while J&J handles US marketing.