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
Reported: May 10, 2017 Initiated: January 5, 2017 #D-0688-2017
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
Details
- Recalling Firm
- The Harvard Drug Group
- Units Affected
- 2,341 cartons
- Distribution
- Nationwide within the US
- Location
- Livonia, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by The Harvard Drug Group. Units affected: 2,341 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 10, 2017. Severity: Moderate. Recall number: D-0688-2017.
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