Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma
Summary
The FDA issued a Class II for Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Sy by AuroMedics Pharma LLC. Reason: Subpotent Drug: Out of specification for assay.
Details
Source
Drug Recall
External ID
D-0020-2023
Action Date
2022-11-02
Status
Terminated
Category
drug
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)
Lot/Code Info: Lot # CFN200020, EXP Nov. 2022
Quantity Affected: 11,520 units
Reason for Recall
Subpotent Drug: Out of specification for assay
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-30
Company
East Windsor, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 39 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
AuroMedics Pharma LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AuroMedics Pharma LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AuroMedics Pharma LLC have FDA actions?
AuroMedics Pharma LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0020-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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