Amgen, Inc. recalls 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
Recalled September 27, 2017 · FDA recall D-1173-2017 · Amgen
Hazard
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection. · FDA Class II
Units
275,380 vials
Sold at
U.S.A. Nationwide
Description
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
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
Manufacturer(s)
Amgen, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →