Recalls / Class II
Class IID-66318-001
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.
- Brand name
- Prolia
- Generic name
- Denosumab
- Active ingredient
- Denosumab
- Route
- Subcutaneous
- NDC
- 55513-710
- FDA application
- BLA125320
- Affected lot / code info
- Lot #: 1037592, Exp 07/15
Why it was recalled
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Recalling firm
- Firm
- Amgen, Inc.
- Manufacturer
- Amgen, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Amgen Center Dr, N/A, Thousand Oaks, California 91320-1730
Distribution
- Quantity
- 4,163 prefilled syringes
- Distribution pattern
- Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.
Timeline
- Recall initiated
- 2013-09-17
- FDA classified
- 2013-11-04
- Posted by FDA
- 2013-11-13
- Terminated
- 2014-06-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-66318-001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.