FDA recall D-0020-2023

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-09-30

Report date

2022-11-02

Termination date

2024-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0020-2023