Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by:
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Summary
The FDA issued a Class II for Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blist by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Reason: Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution..
Details
Source
Drug Recall
External ID
D-0584-2024
Action Date
2024-07-10
Status
Terminated
Category
drug
Product Description
Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614
Lot/Code Info: Lot code: M04614, Exp 09/30/2024
Quantity Affected: 864 cartons
Reason for Recall
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Distribution
Nationwide. No foreign consignees.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-18
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 53 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-0584-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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