Drug Enforcement D-0020-2023

Subpotent Drug: Out of specification for assay

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Status

Terminated

Classification

Class II

Report Date

November 2, 2022

Termination Date

September 18, 2024

Product Information

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)
Product quantity
11,520 units
Reason for recall
Subpotent Drug: Out of specification for assay
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
AuroMedics Pharma LLC
Address
279 Princeton Hightstown Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0020-2023
Event ID
90925
Recall initiation date
September 30, 2022
Center classification date
October 24, 2022
Code info
Lot # CFN200020, EXP Nov. 2022
More code info
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