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
Reason for recall: Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Recall initiated: 20170913
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated