FDA-Drug2024-07-10Class II
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
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Sold states
Nationwide. No foreign consignees.
Affected count
864 cartons
Manufactured in
341 Mason Rd, N/A, La Vergne, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0584-2024Don't want to check this manually?
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