FDA recall D-0689-2017

The Harvard Drug Group · Class II · drug

Product

Fluconazole Tablets, USP, 200 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 0904-6501-61

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide within the US

Key facts

Status: Terminated
Initiation date: 2017-01-05
Report date: 2017-05-10
Termination date: 2017-08-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0689-2017