Drug product
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61
D-0689-2017
Product summary
- Event
- Event 77106
- Status
- Terminated
- Classification
- Class II
- Quantity
- 914 cartons
- Official record key
drug-enforcement:D-0689-2017
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #:T-00519, Exp. 01-17
Distribution pattern: Nationwide within the US
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications