D-0584-2024 Class II Terminated
FDA drug recall D-0584-2024 was initiated by The Harvard Drug Group LLC Dba Major Pharmaceuticals And Rugby Laboratories on Jun 18, 2024 and is designated Class II. Reason for recall: Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution. The recall status is terminated (terminated Dec 22, 2025). Affected quantity: 864 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 10, 2024
- Initiation Date
- Jun 18, 2024
- Termination Date
- Dec 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 864 cartons
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
Reason for Recall
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Distribution Pattern
Nationwide. No foreign consignees.
Code Information
Lot code: M04614, Exp 09/30/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0584-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026