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D-0020-2023 Class II Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0020-2023 was initiated by AuroMedics Pharma LLC on Sep 30, 2022 and is designated Class II. Reason for recall: Subpotent Drug: Out of specification for assay The recall status is terminated (terminated Sep 18, 2024). Affected quantity: 11,520 units.

Recall Details

Product Type: Drugs
Report Date: Nov 2, 2022
Initiation Date: Sep 30, 2022
Termination Date: Sep 18, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11,520 units

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)

Reason for Recall

Subpotent Drug: Out of specification for assay

Distribution Pattern

Nationwide in the USA

Code Information

Lot # CFN200020, EXP Nov. 2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0020-2023
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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