FDA-Drug2013-11-13Class II
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.
Amgen, Inc.
Hazard
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Sold states
Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.
Affected count
4,163 prefilled syringes
Manufactured in
1 Amgen Center Dr, N/A, Thousand Oaks, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66318-001Don't want to check this manually?
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