Amgen, Inc. recalls Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amg
Recalled November 13, 2013 · FDA recall D-66318-001 · Amgen
Hazard
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination. · FDA Class II
Units
4,163 prefilled syringes
Sold at
Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.
Description
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
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.
Manufacturer(s)
Amgen, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →