Drug product
Fluconazole Tablets, USP, 100 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 0904-6500-61
D-0688-2017
Product summary
- Event
- Event 77106
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,341 cartons
- Official record key
drug-enforcement:D-0688-2017
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot#: T-00520, EXP 02-17, T-00632, T-00699, EXP. 04-17
Distribution pattern: Nationwide within the US
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications