HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactu
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Summary
The FDA issued a Class II for HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 bliste by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Reason: an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could.
Details
Source
Drug Recall
External ID
D-0324-2024
Action Date
2024-02-21
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: T04680, Exp. Date 6/2024
Quantity Affected: 8,198 units
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.
Distribution
The product was distributed nationwide within the United States.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-09
Company
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 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 FDA actions in our database, including 24 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 LLC dba Major Pharmaceuticals and Rugby Laboratories) 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 LLC dba Major Pharmaceuticals and Rugby Laboratories have FDA actions?
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0324-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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