Vasopressin Injection, Solution
FDA Recall NDC 0517-1020
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Vasopressin (NDC 0517-1020). A significant event, classified as Class II, was initiated on May 13, 2024 by American Regent, Inc.. The reported reason for this action was: "Subpotent product in addition to having out-of-specification results for impurities."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
May 2024 Class II Recall: Subpotent product in addition to having out-of-specification results for impurities.
Recall Number
Class II Terminated
Subpotent product in addition to having out-of-specification results for impurities.
May 13, 2024
May 29, 2024
2,352 vials
Recall Profile & Regulatory Data
Event ID
94619
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
American Regent, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Dec 22, 2025
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
Batch or Lot Expiration Information
Lot# : 23061L1C0, Exp 1/31/2025
Affected Packages Involved in this Recall
0517-1020-01Product
0517-1020-25Product
0517-1030-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
