Amgen, Inc. Provisional
FDA Flags (8)
Class II RecallJul 2026
Amgen, Inc.
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC
Classification: Class II
Class II RecallJul 2026
Amgen, Inc.
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC
Classification: Class II
Class II RecallJul 2026
Amgen, Inc.
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand O
Classification: Class II
Class II RecallJul 2026
Amgen, Inc.
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand O
Classification: Class II
Class II RecallJul 2026
Amgen, Inc.
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand O
Classification: Class II
Class II RecallMar 2025
Amgen, Inc.
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use O
Classification: Class II
Class II RecallMar 2025
Amgen, Inc.
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous o
Classification: Class II
Class II RecallMay 2022
Amgen, Inc.
MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Ma
Classification: Class II