Drug 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
D-0584-2024
Product summary
- Event
- Event 94835
- Status
- Terminated
- Classification
- Class II
- Quantity
- 864 cartons
- Official record key
drug-enforcement:D-0584-2024
Official wording
Reason: Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Code information: Lot code: M04614, Exp 09/30/2024
Distribution pattern: Nationwide. No foreign consignees.
Derived failure modes
-
Potency or specification failure
out of specification