Desmopressin Acetate Tablet
FDA Recall NDC 23155-490

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 Desmopressin Acetate (NDC 23155-490). A significant event, classified as Class II, was initiated on Nov 23, 2022 by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The reported reason for this action was: "Subpotent Drug"

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

November 2022 Class II Recall: Subpotent Drug

Recall Number
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Nov 23, 2022
Reported
Dec 07, 2022
Quantity
13805 Bottles each containing 100 tablets

Recall Profile & Regulatory Data

Event ID
91171
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Heritage Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Dec 13, 2023
Product Description
Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01
Batch or Lot Expiration Information
Lot# : 220440A, Exp. Date 05/2024
Affected Packages Involved in this Recall
23155-489-01Product
23155-489-05Product
23155-490-01Product
23155-490-05Product

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.