FDA Drug Class II — Moderate

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

Hazard

Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.

Products

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.
Brand
Amgen, Inc.
UPC
Lot #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18

Units Affected

275,380 vials