AuroMedics Pharma LLC recalls Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma
Recalled November 2, 2022 · FDA recall D-0020-2023 · AuroMedics Pharma
Hazard
Subpotent Drug: Out of specification for assay · FDA Class II
Units
11,520 units
Sold at
Nationwide in the USA
Description
Subpotent Drug: Out of specification for assay
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)
Manufacturer(s)
AuroMedics Pharma LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →