FDA Drug recall D-0688-2017
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 0…
- FDA Drug
- Class II
- terminated
- Published 2017-05-10
On 2017-05-10 the FDA classified a Class II recall of Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 0… by The Harvard Drug Group, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0688-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-05 |
| Published | 2017-05-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
Product
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
Failed Dissolution Specifications
Identifiers
| ndc | 0904-6500-06 |
|---|---|
| ndc | 0904-6500-61 |
| ndc | 0904-6501-06 |
| ndc | 0904-6501-61 |
| code_info | Lot#: T-00520, EXP 02-17, T-00632, T-00699, EXP. 04-17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0688-2017%22
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