February 2024 FDA Recall Drug by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
D-0324-2024 - an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

This Class II drug recall was voluntarily initiated by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories on February 9, 2024 for the product Drug. The FDA reported the reason for recall as an out of specification result obtained during routine stability testing for impurities. there is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0324-2024

Reason for Recall
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Initiated
02-09-2024
Reported
02-21-2024
Quantity
8,198 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93929
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.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
The product was distributed nationwide within the United States.
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.
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61

Batch or Lot Expiration Information

Lot# : T04680, Exp. Date 6/2024