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
FDA recall notice · announced May 29, 2024 · American Regent
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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 for recall
Subpotent product in addition to having out-of-specification results for impurities.
Notes
Distribution: USA Nationwide
Lot/code information: Lot #: 23061L1C0, Exp 1/31/2025
Quantity: 2,352 vials
Status: Terminated
Products in this recall event:
- 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 (D-0507-2024)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.