Drug product
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12
D-0451-2017
Product summary
- Event
- Event 76122
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59,440 blister cards
- Official record key
drug-enforcement:D-0451-2017
Official wording
Reason: Failed Dissolution Specifications; 18 month stability time point
Code information: C500222, C500515, and C500517, exp 12/2016, C502343, exp 03/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications