FDA Drug recall D-0452-2017
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's…
- FDA Drug
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's… by Dr Reddy S Laboratories, citing failed Dissolution Specifications; 18 month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0452-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-28 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Reason
Failed Dissolution Specifications; 18 month stability time point
Identifiers
| ndc | 55111-143-30 |
|---|---|
| ndc | 55111-143-01 |
| ndc | 55111-143-05 |
| ndc | 55111-143-79 |
| ndc | 55111-143-78 |
| ndc | 55111-144-30 |
| ndc | 55111-144-01 |
| ndc | 55111-144-05 |
| ndc | 55111-144-79 |
| ndc | 55111-144-78 |
| ndc | 55111-145-71 |
| ndc | 55111-145-12 |
| ndc | 55111-146-30 |
| ndc | 55111-146-01 |
| ndc | 55111-146-05 |
| ndc | 55111-146-79 |
| ndc | 55111-146-78 |
| code_info | a) 30 count C500228, exp 12/2016, C500848 and C500850, exp 01/2017 C503651 and C503653, exp 04/2017, b) 100 count C50…a) 30 count C500228, exp 12/2016, C500848 and C500850, exp 01/2017 C503651 and C503653, exp 04/2017, b) 100 count C500226, exp 12/2016, C500848, C500850, exp 01/2017, C503649 and C503653, exp 04/2017 |
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-0452-2017%22
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