Recall: D-0020-2023

Class II - Potentially Harmful

Class IIClassification

2022-09-30Initiated

TerminatedStatus

AuroMedics Pharma LLCFirm

Product

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)

Reason

Subpotent Drug: Out of specification for assay

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.