FDAFDA · Food and drugs·Recall number D-66318-001
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.
Published November 13, 2013 · Recall initiated: September 17, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PROLIA
- Manufacturer
- Amgen, Inc.
- Distributor
- Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.
- UPC
- 355513710015
- Lot
- Lot #: 1037592, Exp 07/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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