Drug product
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
D-0449-2017
Product summary
- Event
- Event 76122
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 2472 bottles, b) 780 bottles
- Official record key
drug-enforcement:D-0449-2017
Official wording
Reason: Failed Dissolution Specifications; 18 month stability time point
Code information: a) 30 count C500221, exp 12/2016, C502342, exp 03/2017 b) 100 count C500221, exp 12/2016, C502342, exp 03/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications