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
Reported: July 10, 2024 Initiated: June 18, 2024 #D-0584-2024
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
Reason for Recall
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Details
- Units Affected
- 864 cartons
- Distribution
- Nationwide. No foreign consignees.
- Location
- La Vergne, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Units affected: 864 cartons.
Why was this product recalled? ▼
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 10, 2024. Severity: Moderate. Recall number: D-0584-2024.
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