FDA Drug recall D-1086-2017
Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thous…
- FDA Drug
- Class II
- terminated
- Published 2017-08-23
On 2017-08-23 the FDA classified a Class II recall of Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thous… by Amgen, citing presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1086-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-04 |
| Published | 2017-08-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Amgen |
| Distribution | PR |
Product
Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01
Reason
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Identifiers
| ndc | 59676-303-00 |
|---|---|
| ndc | 59676-303-01 |
| ndc | 59676-304-00 |
| ndc | 59676-304-01 |
| ndc | 59676-310-00 |
| ndc | 59676-310-01 |
| ndc | 59676-310-02 |
| ndc | 59676-302-00 |
| ndc | 59676-302-01 |
| ndc | 59676-340-00 |
| ndc | 59676-340-01 |
| ndc | 59676-312-00 |
| ndc | 59676-312-04 |
| ndc | 59676-320-00 |
| ndc | 59676-320-04 |
| code_info | Lot #: G290491A, G290491B, Exp. 06/18 |
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-1086-2017%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.