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-0452-2017

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief