Procrit — Class II drug recall D-1173-2017
Terminated recall by Amgen, Inc., reported 2017-09-27, distributed nationwide. Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspecti
| Recall number | D-1173-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amgen, Inc., Thousand Oaks, CA, United States |
| Recall initiated | 2017-09-13 |
| Classified | 2017-09-19 |
| Reported by FDA | 2017-09-27 |
| Terminated | 2018-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 275,380 vials |
| Reason classes | foreign material, specification failure |
| NDC | 59676-0302, 59676-0302-00, 59676-0302-01, 59676-0303, 59676-0303-00, 59676-0303-01, 59676-0304, 59676-0304-00, 59676-0304-01, 59676-0310, 59676-0310-00, 59676-0310-01, 59676-0310-02, 59676-0312, 59676-0312-00, 59676-0312-04, 59676-0320, 59676-0320-00, 59676-0320-04, 59676-0340, 59676-0340-00, 59676-0340-01 |
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 for recall
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1173-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.