FDA-Drug2017-02-08Class II

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

Dr. Reddy's Laboratories, Inc.
Hazard

Failed Dissolution Specifications; 18 month stability time point

Sold states
Nationwide
Affected count
a) 2472 bottles, b) 780 bottles
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0449-2017

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