Procrit Epoetin Alfa 40 — Class II drug recall D-1086-2017
Terminated recall by Amgen, Inc., reported 2017-08-23, distributed in PR. Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
| Recall number | D-1086-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amgen, Inc., Thousand Oaks, CA, United States |
| Recall initiated | 2017-08-04 |
| Classified | 2017-08-14 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2018-03-29 |
| Distributed | PR |
| Quantity | 175,632 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 |
| Lot numbers | 06/18, G290491A, G290491B |
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 for recall
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
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-1086-2017. 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.