Drug 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.
D-66318-001
Product summary
- Firm
- Amgen, Inc.
- Event
- Event 66318
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,163 prefilled syringes
- Official record key
drug-enforcement:D-66318-001
Official wording
Reason: Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Code information: Lot #: 1037592, Exp 07/15
Distribution pattern: Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter