Recalls / Class II
Class IID-0020-2023
Product
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)
- Brand name
- Fondaparinux Sodium
- Generic name
- Fondaparinux Sodium
- Active ingredient
- Fondaparinux Sodium
- Route
- Subcutaneous
- NDCs
- 55150-230, 55150-231, 55150-232, 55150-233
- FDA application
- ANDA206918
- Affected lot / code info
- Lot # CFN200020, EXP Nov. 2022
Why it was recalled
Subpotent Drug: Out of specification for assay
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 11,520 units
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-09-30
- FDA classified
- 2022-10-24
- Posted by FDA
- 2022-11-02
- Terminated
- 2024-09-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0020-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.