Amgen Inc Product Recalls

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

Class IIModerate

FDAFeb 27, 2025Nationwide• Amgen, Inc.

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

Class IIModerate

FDAFeb 27, 2025Nationwide• Amgen, Inc.

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

Class IIModerate

FDAMay 2, 2022Nationwide• Amgen, Inc.

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

Class IIModerate

FDASep 13, 2017Nationwide• Amgen, Inc.

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

Class IIModerate

FDAAug 4, 2017Nationwide• Amgen, Inc.

Lack of Assurance of Sterility: Potential cracks in glass vials

Class IIModerate

FDADec 15, 2016Nationwide• Amgen, Inc.

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

Class IIModerate

FDASep 17, 2013Nationwide• Amgen, Inc.

Amgen, Inc. Recalls