hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMA
Summary
The FDA issued a Class II for hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs by The Harvard Drug Group. Reason: Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities..
Details
Source
Drug Recall
External ID
D-0653-2022
Action Date
2022-03-23
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: T03755, T03756, Exp. Date 03/2023
Quantity Affected: 5,953 cartons
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Distribution
Nationwide within USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-24
Company
Livonia, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 25 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
The Harvard Drug Group has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (The Harvard Drug Group) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Harvard Drug Group have FDA actions?
The Harvard Drug Group has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0653-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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