FDAFDA · Food and drugs·Recall number D-0584-2024
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
Published July 10, 2024 · Recall initiated: June 18, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Distributor
- Nationwide. No foreign consignees.
- Lot
- Lot code: M04614, Exp 09/30/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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