# FDA recall D-0610-2017

> **AVKARE Inc.** · Class II · drug recall initiated 2017-02-15.

## Product

Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for:  AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13

## Reason for recall

Failed impurities/ degradation specifications: Product was above specification for unknown impurities.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0610-2017
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-15
- **Report date:** 2017-03-29
- **Termination date:** 2022-06-01

- **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-0610-2017

## Citation

> AI Analytics. FDA recall D-0610-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0610-2017. Source: US FDA. Licensed CC0.

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