Overview of recall records associated with Amgen, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 7.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Defective container: loose crimp defect, potential loss of container integrity.
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Lack of Assurance of Sterility: Potential cracks in glass vials
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
This page summarizes recall records in which the official source identifies Amgen, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
