February 2022 FDA Recall Drug by The Harvard Drug Group
D-0653-2022 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by The Harvard Drug Group on February 24, 2022 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0653-2022

Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Initiated
02-24-2022
Reported
03-23-2022
Quantity
5,953 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89663
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
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 within USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-16-2023
Product Description About Product Description
Full technical description of the product.
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61

Batch or Lot Expiration Information

Lot# : T03755, T03756, Exp. Date 03/2023