Amgen Recalls

7 recalls on record in the United States

drugs: 7
drugs Class II
2025-03-26

Amgen, Inc. recalls Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Singl

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

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drugs Class II
2025-03-26

Amgen, Inc. recalls Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

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drugs Class II
2022-05-18

Amgen, Inc. recalls MVASI (bevacizumab-awwb), Injection, For Intravenous Infusio

Defective container: loose crimp defect, potential loss of container integrity.

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drugs Class II
2017-09-27

Amgen, Inc. recalls Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box

Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.

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drugs Class II
2017-08-23

Amgen, Inc. recalls Procrit Epoetin Alfa 40,000 units/mL single use vial For Int

Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.

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drugs Class II
2016-12-28

Amgen, Inc. recalls AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial,

Lack of Assurance of Sterility: Potential cracks in glass vials

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drugs Class II
2013-11-13

Amgen, Inc. recalls Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use

Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.

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