# FDA recall D-0243-2021

> **Bausch Health Companies, Inc.** · Class III · drug recall initiated 2021-01-07.

## Product

Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05

## Reason for recall

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0243-2021
- **Recalling firm:** Bausch Health Companies, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-01-07
- **Report date:** 2021-02-03
- **Termination date:** 2022-02-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0243-2021

## Citation

> AI Analytics. FDA recall D-0243-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0243-2021. Source: US FDA. Licensed CC0.

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