# FDA recall D-1094-2017

> **AVKARE Inc.** · Class III · drug recall initiated 2017-07-19.

## Product

Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12

## Reason for recall

Failed impurities/degradation specifications: Out of specification for a related compound C.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1094-2017
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-07-19
- **Report date:** 2017-08-23
- **Termination date:** 2019-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1094-2017

## Citation

> AI Analytics. FDA recall D-1094-2017. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1094-2017. Source: US FDA. Licensed CC0.

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