Drug Recall: 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 1
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · June 18, 2024
Reason for Recall
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
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
Distribution
Nationwide. No foreign consignees.
States Affected
NATIONWIDE
Quantity Affected
864 cartons
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0584-2024
Status: terminated
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