Drug 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
D-1086-2017
Product summary
- Firm
- Amgen, Inc.
- Event
- Event 77889
- Status
- Terminated
- Classification
- Class II
- Quantity
- 175,632 vials
- Official record key
drug-enforcement:D-1086-2017
Official wording
Reason: Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Code information: Lot #: G290491A, G290491B, Exp. 06/18
Distribution pattern: United States including Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
particulate matter