FDA Drug recall 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-…
- FDA Drug
- Class II
- terminated
- Published 2022-11-02
On 2022-11-02 the FDA classified a Class II recall of Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-… by Auromedics Pharma, citing subpotent Drug: Out of specification for assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0020-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-09-30 |
| Published | 2022-11-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Auromedics Pharma |
| Distribution | US |
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
Subpotent Drug: Out of specification for assay
Identifiers
| ndc | 55150-230-00 |
|---|---|
| ndc | 55150-230-02 |
| ndc | 55150-230-10 |
| ndc | 55150-231-00 |
| ndc | 55150-231-02 |
| ndc | 55150-231-10 |
| ndc | 55150-232-00 |
| ndc | 55150-232-02 |
| ndc | 55150-232-10 |
| ndc | 55150-233-00 |
| ndc | 55150-233-02 |
| ndc | 55150-233-10 |
| code_info | Lot # CFN200020, EXP Nov. 2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0020-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.