Reported Nov 13, 2013 · Terminated
Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by:…
Amgen, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amgen, Inc. · 1 Amgen Center Dr · Thousand Oaks, CA · 91320-1730
Is this the product you have?
- Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only
- Manufactured byAmgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5
- Lot codes and dates
Lot #: 1037592Exp 07/15
- Amount recalled
- 4,163 prefilled syringes
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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