D-0688-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 10, 2017
- Initiation Date
- January 5, 2017
- Termination Date
- August 4, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,341 cartons
Product Description
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
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide within the US
Code Information
Lot#: T-00520, EXP 02-17, T-00632, T-00699, EXP. 04-17