June 2024 FDA Recall Drug by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
D-0584-2024 - Failed dissolution specifications

This Class II drug recall was voluntarily initiated by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories on June 18, 2024 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0584-2024

Reason for Recall
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Initiated
06-18-2024
Reported
07-10-2024
Quantity
864 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94835
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide. No foreign consignees.
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.
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

Batch or Lot Expiration Information

Lot# Lot code: M04614, Exp 09/30/2024