US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 30, 2022 (4 years ago)

Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Subpotent Drug: Out of specification for assay

What was recalled

Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)

Recalling firm
AuroMedics Pharma LLC
NDC code
55150-232-10
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0020-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.