FDA Drug recall D-0507-2024
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Re…
- FDA Drug
- Class II
- terminated
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class II recall of Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Re… by American Regent, citing subpotent product in addition to having out-of-specification results for impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0507-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-05-13 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Regent |
| Distribution | US |
Product
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
Reason
Subpotent product in addition to having out-of-specification results for impurities.
Identifiers
| ndc | 0517-1020-01 |
|---|---|
| ndc | 0517-1020-25 |
| ndc | 0517-1030-01 |
| code_info | Lot #: 23061L1C0, Exp 1/31/2025 |
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-0507-2024%22
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