American Regent, Inc.: Drug Recall

Recall #D-0507-2024 · 05/13/2024

Class II: Risk

Recall Details

Recall Number: D-0507-2024
Classification: Class II
Product Type: Drug
Recalling Firm: American Regent, Inc.
Status: Terminated
Date Initiated: 05/13/2024
Location: New Albany, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,352 vials

Reason for Recall

Subpotent product in addition to having out-of-specification results for impurities.

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

Distribution Pattern

USA Nationwide

Other Recalls by American Regent, Inc.

Class II: Risk 04/18/2025

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II: Risk 04/18/2025

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II: Risk 11/11/2024

Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II: Risk 11/11/2024

Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II: Risk 11/11/2024

Presence of Particulate Matter: Potential for glass delamination from the vials.

View all recalls by American Regent, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.