FDA-Drug2017-08-23Class II
Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01
Amgen, Inc.
Hazard
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Sold states
United States including Puerto Rico
Affected count
175,632 vials
Manufactured in
1 Amgen Center Dr, N/A, Thousand Oaks, CA, United States
Products
Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1086-2017Don't want to check this manually?
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