D-0584-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 10, 2024
- Initiation Date
- June 18, 2024
- Termination Date
- December 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