# FDA recall D-0451-2017

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2016-12-28.

## Product

Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12

## Reason for recall

Failed Dissolution Specifications; 18 month stability time point

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0451-2017
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-28
- **Report date:** 2017-02-08
- **Termination date:** 2017-10-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0451-2017

## Citation

> AI Analytics. FDA recall D-0451-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0451-2017. Source: US FDA. Licensed CC0.

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