Drug recall D-0452-2017
Product
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Reason for recall
Failed Dissolution Specifications; 18 month stability time point
Lots and codes
a) 30 count C500228, exp 12/2016, C500848 and C500850, exp 01/2017 C503651 and C503653, exp 04/2017, b) 100 count C500226, exp 12/2016, C500848, C500850, exp 01/2017, C503649 and C503653, exp 04/2017
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- a) 38,832 and b) 5,064 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 28, 2016
- Terminated
- October 19, 2017
Related products
- Fluconazole – drug information
- NDC 55111-143 Fluconazole · Fluconazole 50 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-145 Fluconazole · Fluconazole 150 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-144 Fluconazole · Fluconazole 100 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-146 Fluconazole · Fluconazole 200 mg/1 · Dr. Reddy's Laboratories Limited