May 2024 FDA Recall Vasopressin by American Regent, Inc.
D-0507-2024 - Subpotent product in addition to having out-of-specification results for impurities.

This Class II drug recall was voluntarily initiated by American Regent, Inc. on May 13, 2024 for the product Vasopressin. The FDA reported the reason for recall as subpotent product in addition to having out-of-specification results for impurities.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0507-2024

Reason for Recall
Subpotent product in addition to having out-of-specification results for impurities.
Initiated
05-13-2024
Reported
05-29-2024
Quantity
2,352 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94619
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Regent, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-22-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

0517-1020-01 Vasopressin
0517-1020-25 Vasopressin
0517-1030-01 Vasopressin