FDA Drug recall D-1173-2017
Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL via…
- FDA Drug
- Class II
- terminated
- Published 2017-09-27
On 2017-09-27 the FDA classified a Class II recall of Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL via… by Amgen, citing presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1173-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-13 |
| Published | 2017-09-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Amgen |
| Distribution | US |
Product
Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044
Reason
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
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 #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18 |
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-1173-2017%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.