FDA-Drug2017-02-08Class II

Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12

Dr. Reddy's Laboratories, Inc.
Hazard

Failed Dissolution Specifications; 18 month stability time point

Sold states
Nationwide
Affected count
59,440 blister cards
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0451-2017

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