Recall: D-0689-2017

Class II - Potentially Harmful

Class IIClassification
2017-01-05Initiated
TerminatedStatus
The Harvard Drug GroupFirm

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

Failed Dissolution Specifications

Distribution

Nationwide within the US

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.