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.
Reported: November 13, 2013 Initiated: September 17, 2013 #D-66318-001
Product Description
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.
Reason for Recall
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Details
- Recalling Firm
- Amgen, Inc.
- Units Affected
- 4,163 prefilled syringes
- Distribution
- Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.
- Location
- Thousand Oaks, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Amgen, Inc.. Units affected: 4,163 prefilled syringes.
Why was this product recalled? ▼
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 13, 2013. Severity: Moderate. Recall number: D-66318-001.
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