FDA Recalls NDC 59676-303 Procrit
Erythropoietin Injection, Solution Intravenous; Subcutaneous

FDA Recalls Enforcement Reports

The last Recall Enforcement Report for Procrit with NDC 59676-303 was initiated on 09-13-2017 as a Class II recall due to presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection. The latest recall number for this product is D-1173-2017 and the recall is currently terminated as of 03-29-2018 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1173-201709-13-201709-27-2017Class II275,380 vialsProcrit (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 19044Terminated
D-1086-201708-04-201708-23-2017Class II175,632 vialsProcrit 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 59676-340-01Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.