AuroMedics Pharma LLC: Drug Recall

Recall #D-0020-2023 · 09/30/2022

Class II: Risk

Recall Details

Recall Number: D-0020-2023
Classification: Class II
Product Type: Drug
Recalling Firm: AuroMedics Pharma LLC
Status: Terminated
Date Initiated: 09/30/2022
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11,520 units

Reason for Recall

Subpotent Drug: Out of specification for assay

Product Description

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)

Distribution Pattern

Nationwide in the USA

Other Recalls by AuroMedics Pharma LLC

Class III: Low Risk 09/26/2022

Presence of Particulate Matter: Piece of metal found in a vial
Class II: Risk 09/26/2022

Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class I: Dangerous 01/26/2022

Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class II: Risk 12/30/2020

Discoloration and failed pH specifications

View all recalls by AuroMedics Pharma LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.