Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx o...

FDA Recall #D-0507-2024 — Class II — May 13, 2024

Recall #D-0507-2024 Date: May 13, 2024 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

American Regent, Inc. — New Albany, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2,352 vials

Distribution

USA Nationwide

Code Information

Lot #: 23061L1C0, Exp 1/31/2025

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated