FDA-Drug2017-05-10Class II

Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61

The Harvard Drug Group
Hazard

Failed Dissolution Specifications

Sold states
Nationwide within the US
Affected count
2,341 cartons
Manufactured in
17177 N Laurel Park Dr Ste 233, Livonia, MI, United States
Products
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0688-2017

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