Class II

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

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.