Recall Enforment Report D-0072-2023

Drug Recall Enforcement Report Class II voluntary initiated by Heritage Pharmaceuticals Inc, originally initiated on 11-23-2022 for the product Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01 The product was recalled due to subpotent drug. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 91171 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0072-2023 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall Subpotent Drug What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 13805 Bottles each containing 100 tablets Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 12-07-2022
Recall Initiation Date 11-23-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Heritage Pharmaceuticals Inc
Code Info Lot #: 220440A, Exp. Date 05/2024 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 23155-489-01; 23155-489-05; 23155-490-01; 23155-490-05
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
23155-489Desmopressin Acetate Desmopressin AcetateTabletOralHeritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.Human Prescription Drug
23155-490Desmopressin Acetate Desmopressin AcetateTabletOralHeritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.Human Prescription Drug