November 2024 FDA Recall Drug by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
D-0045-2025 - Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

This Class III drug recall was voluntarily initiated by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories on November 5, 2024 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; during routine stability testing for impurities.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0045-2025

Reason for Recall
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Initiated
11-05-2024
Reported
11-20-2024
Quantity
25814 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95700
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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.
Nationwide in the US.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2025
Product Description About Product Description
Full technical description of the product.
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.

Batch or Lot Expiration Information

Lot# : T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025