Class II
Terminated
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
This recall has been terminated (originally issued July 10, 2024).
- Recall Initiated
- June 18, 2024
- Posted
- July 10, 2024
- Recall Number
- D-0584-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 864 cartons
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Distribution
Nationwide. No foreign consignees.
Lot / Code Info
Lot code: M04614, Exp 09/30/2024
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