RecallDepth
Class II Terminated

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

Company
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Recall Initiated
June 18, 2024
Posted
July 10, 2024
Recall Number
D-0584-2024
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
864 cartons
Firm Location
La Vergne, TN, United States

Reason for Recall

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

Distribution

Nationwide. No foreign consignees.

Lot / Code Info

Lot code: M04614, Exp 09/30/2024

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