FDA Drug recall D-0019-2025
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, M…
- FDA Drug
- Class II
- terminated
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, M… by Fresenius Kabi Compounding, citing cGMP violations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0019-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-09-25 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Compounding |
| Distribution | US |
Product
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
Reason
cGMP violations
Identifiers
| code_info | Lot # C274-000038582, exp. date 29-Nov-24 |
|---|
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-0019-2025%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.