# FDA recall D-0379-2015

> **Valeant Pharmaceuticals North America LLC** · Class II · drug recall initiated 2014-12-31.

## Product

Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four  6 g vials, 100 mL, Distributed by: Valeant Pharmaceuticals North America, Bridgewater, NJ 08807 USA, NDC 0187-0007-14.

## Reason for recall

Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.

## Distribution

Nationwide and Australia

## Key facts

- **Recall number:** D-0379-2015
- **Recalling firm:** Valeant Pharmaceuticals North America LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-12-31
- **Report date:** 2015-01-28
- **Termination date:** 2017-10-04

- **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-0379-2015

## Citation

> AI Analytics. FDA recall D-0379-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0379-2015. Source: US FDA. Licensed CC0.

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