NDC 0904-6501

Fluconazole 200 mg tablet

On the label: Major Pharmaceuticals. It's repackaged: Major Pharmaceuticals rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-146.

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

Jan 5, 2017 · Class II · The Harvard Drug Group
Failed Dissolution Specifications
Lots: Lot#: T-00520, EXP 02-17, T-00632, T-00699, EXP. 04-17
Jan 5, 2017 · Class II · The Harvard Drug Group
Failed Dissolution Specifications
Lots: Lot #:T-00519, Exp. 01-17
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.

Generic drug: Fluconazole: every company that makes it
Form: tablet, oral
Strength: 200 mg
Approval: ANDA ANDA076658
On the market since: Jun 25, 2015
Package NDCs: 0904-6501-06 0904-6501-61
Official label: DailyMed (National Library of Medicine), updated Mar 19, 2026

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