FDA-Drug2017-02-08Class II
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
Dr. Reddy's Laboratories, Inc.
Hazard
Failed Dissolution Specifications; 18 month stability time point
Sold states
Nationwide
Affected count
a) 38,832 and b) 5,064 bottles
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0452-2017Don't want to check this manually?
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