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 for recall: Subpotent Drug: Out of specification for assay
Recall initiated: 20220930
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated