NDC 72189-143
Fluconazole 150 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-145.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Medchal-Malkajgiri, India | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 8 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · relabels it
Recalls
- Dec 28, 2016 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications; 18 month stability time point
Lots: a) 30 count C500221, exp 12/2016, C502342, exp 03/2017 b) 100 count C500221, exp 12/2016, C502342, exp 03/2017 - Dec 28, 2016 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications; 18 month stability time point
Lots: a) 30 count C500224, exp 12/2016, C500846, exp 01/2017 b) 100 count C500224, exp 12/2016, exp 12/2016, C501608, exp 02/2017 and C503655, exp 04/2017 - Dec 28, 2016 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications; 18 month stability time point
Lots: C500222, C500515, and C500517, exp 12/2016, C502343, exp 03/2017 - Dec 28, 2016 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications; 18 month stability time point
Lots: 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
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluconazole: every company that makes it
- Form
- tablet, oral
- Strength
- 150 mg
- Approval
- ANDA ANDA076658
- On the market since
- Nov 12, 2020
- Package NDCs
72189-143-01- Official label
- DailyMed (National Library of Medicine), updated Jan 17, 2025
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