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

FDA recall notice · announced August 23, 2017 · Amgen

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: United States including Puerto Rico
Lot/code information: Lot #: G290491A, G290491B, Exp. 06/18
Quantity: 175,632 vials
Status: Terminated
Products in this recall event:
- 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, (D-1086-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.