PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 29, 2024 Initiated: May 13, 2024 #D-0507-2024

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.

Details

Recalling Firm
American Regent, Inc.
Units Affected
2,352 vials
Distribution
USA Nationwide
Location
New Albany, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by American Regent, Inc.. Units affected: 2,352 vials.
Why was this product recalled?
Subpotent product in addition to having out-of-specification results for impurities.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 29, 2024. Severity: Moderate. Recall number: D-0507-2024.