Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe recall — FDA D-0020-2023
Subpotent Drug: Out of specification for assay
Overview of recall records associated with AuroMedics Pharma LLC, including dates, categories and classifications where available.
Classification mix: Class II: 2, Class III: 1.
Subpotent Drug: Out of specification for assay
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Presence of Particulate Matter: Piece of metal found in a vial
This page summarizes recall records in which the official source identifies AuroMedics Pharma LLC 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.