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, U

FDA recall notice · announced July 10, 2024 · The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: Nationwide. No foreign consignees.
Lot/code information: Lot code: M04614, Exp 09/30/2024
Quantity: 864 cartons
Status: Terminated
Products in this recall event:
- 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 (D-0584-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.