FDA Drug recall D-0015-2025
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 7…
- FDA Drug
- Class II
- terminated
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 7… by Fresenius Kabi Compounding, citing cGMP violations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0015-2025 |
| 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
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
Reason
cGMP violations
Identifiers
| code_info | Lot # C274-000037046, exp. date 13-Oct-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-0015-2025%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.