The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by:
Recalled July 10, 2024 · FDA recall D-0584-2024 · The Harvard Drug Group LLC
Hazard
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution. · FDA Class II
Units
864 cartons
Sold at
Nationwide. No foreign consignees.
Description
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
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
Manufacturer(s)
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →