Drug 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
D-1173-2017
Product summary
- Firm
- Amgen, Inc.
- Event
- Event 78110
- Status
- Terminated
- Classification
- Class II
- Quantity
- 275,380 vials
- Official record key
drug-enforcement:D-1173-2017
Official wording
Reason: Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Code information: Lot #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulate matter