# FDA recall D-0689-2017

> **The Harvard Drug Group** · Class II · drug recall initiated 2017-01-05.

## Product

Fluconazole Tablets, USP, 200 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  0904-6501-61

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide within the US

## Key facts

- **Recall number:** D-0689-2017
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-01-05
- **Report date:** 2017-05-10
- **Termination date:** 2017-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Livonia, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0689-2017

## Citation

> AI Analytics. FDA recall D-0689-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0689-2017. Source: US FDA. Licensed CC0.

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