FDAFDA · Food and drugs·Recall number D-0020-2023
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)
Published November 2, 2022 · Recall initiated: September 30, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Out of specification for assay
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FONDAPARINUX SODIUM
- Manufacturer
- AuroMedics Pharma LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot # CFN200020, EXP Nov. 2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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