Drug 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
D-0507-2024
Product summary
- Event
- Event 94619
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,352 vials
- Official record key
drug-enforcement:D-0507-2024
Official wording
Reason: Subpotent product in addition to having out-of-specification results for impurities.
Code information: Lot #: 23061L1C0, Exp 1/31/2025
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent