RecallDepth
Class II Terminated

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)

Company
Auromedics Pharma Llc
Recall Initiated
September 30, 2022
Posted
November 2, 2022
Recall Number
D-0020-2023
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
11,520 units
Firm Location
East Windsor, NJ, United States

Reason for Recall

Subpotent Drug: Out of specification for assay

Distribution

Nationwide in the USA

Lot / Code Info

Lot # CFN200020, EXP Nov. 2022

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