Golimumab (Simponi) Injection
February 22, 2011
Centocor Ortho Biotech is voluntarily recalling a single lot of golimumab (Simponi) 50 mg SmartJect autoinjector (lot #09D071.AC). Some autoinjectors are malfunctioning and the full dose of golimumab may not be injected. The Simponi SmartJect autoinjector is on shortage due to this recall and the company estimates a release date of late-March, 2011. Simponi prefilled syringes are not affected. Healthcare professionals should educate patients who need to transition from Simponi SmartJect autoinjectors to prefilled syringes.
Avoid administering the affected product and return to the manufacturer. Healthcare providers with questions may contact Centocor Ortho Biotech at 877-526-7736. Report adverse events to FDA’s MedWatch program.
Additional information is available at the following links:
- Centocor Ortho Biotech Safety Information:
- Centocor Ortho Biotech Patient Information Sheet on Simponi Prefilled Syringes:
February 22, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.