November 2022 FDA Recall Desmopressin Acetate by Heritage Pharmaceuticals Inc
D-0072-2023 - Subpotent Drug
This Class II drug recall was voluntarily initiated by Heritage Pharmaceuticals Inc on November 23, 2022 for the product Desmopressin Acetate. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0072-2023
Subpotent Drug
11-23-2022
12-07-2022
13805 Bottles each containing 100 tablets
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Heritage Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
12-13-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# : 220440A, Exp. Date 05/2024
