FDA Drug recall D-0226-2017
AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactu…
- FDA Drug
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactu… by Amgen, citing lack of Assurance of Sterility: Potential cracks in glass vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0226-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-15 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Amgen |
| Distribution | PR |
Product
AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01
Reason
Lack of Assurance of Sterility: Potential cracks in glass vials
Identifiers
| ndc | 76075-101-01 |
|---|---|
| ndc | 76075-101-21 |
| ndc | 76075-102-01 |
| ndc | 76075-102-21 |
| ndc | 76075-103-01 |
| ndc | 76075-103-21 |
| code_info | Lot #1071559, 1071629; Exp. 05/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class II · 2026-07-01 · Amgen - Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy
FDA Drug · Class II · 2026-07-01 · Amgen - Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799,…
FDA Drug · Class II · 2026-07-01 · Amgen - Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx…
FDA Drug · Class II · 2026-07-01 · Amgen
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0226-2017%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.