Fondaparinux Sodium Injection — Class II drug recall D-0020-2023
Terminated recall by AuroMedics Pharma LLC, reported 2022-11-02, distributed nationwide. Subpotent Drug: Out of specification for assay
| Recall number | D-0020-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2022-09-30 |
| Classified | 2022-10-24 |
| Reported by FDA | 2022-11-02 |
| Terminated | 2024-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 11,520 units |
| Reason classes | potency, specification failure |
| NDC | 55150-0230, 55150-0230-00, 55150-0230-02, 55150-0230-10, 55150-0231, 55150-0231-00, 55150-0231-02, 55150-0231-10, 55150-0232, 55150-0232-00, 55150-0232-02, 55150-0232-10, 55150-0233, 55150-0233-00, 55150-0233-02, 55150-0233-10 |
| Lot numbers | CFN200020 |
| Expiration dates | 2022-11-20 |
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)
Reason for recall
Subpotent Drug: Out of specification for assay
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0020-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.