FDA recall D-0584-2024

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Class II · drug

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

Reason for recall

Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

Distribution

Nationwide. No foreign consignees.

Key facts

Status: Terminated
Initiation date: 2024-06-18
Report date: 2024-07-10
Termination date: 2025-12-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0584-2024