# FDA recall D-0631-2021

> **AVKARE Inc.** · Class III · drug recall initiated 2021-06-09.

## Product

Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13

## Reason for recall

Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.

## Distribution

Distributed in Los Angeles California

## Key facts

- **Recall number:** D-0631-2021
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-06-09
- **Report date:** 2021-06-23
- **Termination date:** 2023-06-02

- **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-0631-2021

## Citation

> AI Analytics. FDA recall D-0631-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0631-2021. Source: US FDA. Licensed CC0.

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