Product: Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA  91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5.
Reason for recall: Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Recall initiated: 20130917
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated