Fondaparinux Sodium Injection, Solution
FDA Recall NDC 55150-232
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fondaparinux Sodium (NDC 55150-232). A significant event, classified as Class II, was initiated on Sep 30, 2022 by Eugia Us Llc. The reported reason for this action was: "Subpotent Drug: Out of specification for assay"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Subpotent Drug: Out of specification for assay
Sep 30, 2022
Nov 02, 2022
11,520 units
Recall Profile & Regulatory Data
Event ID
90925
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 18, 2024
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)
Batch or Lot Expiration Information
Lot# CFN200020, EXP Nov. 2022
Affected Packages Involved in this Recall
55150-230-00Product
55150-230-02Product
55150-230-10Product
55150-231-00Product
55150-231-02Product
55150-231-10Product
55150-232-00Product
55150-232-02Product
55150-232-10Product
55150-233-00Product
55150-233-02Product
55150-233-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
