FDA-Drug2017-09-27Class II
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
Amgen, Inc.
Hazard
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Sold states
U.S.A. Nationwide
Affected count
275,380 vials
Manufactured in
1 Amgen Center Dr, N/A, Thousand Oaks, CA, United States
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. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1173-2017Don't want to check this manually?
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