FDA Drug recall 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 Lt…
- FDA Drug
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Lt… by Amgen, citing presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-66318-001 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-17 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Amgen |
| Distribution | US |
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.
Reason
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Identifiers
| upc | 355513710015 |
|---|---|
| ndc | 55513-710-01 |
| ndc | 55513-710-21 |
| code_info | Lot #: 1037592, Exp 07/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-66318-001%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.