# FDA recall D-0055-2019

> **Product Quest Manufacturing LLC** · Class II · drug recall initiated 2018-08-03.

## Product

OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Division of Valeant Pharmaceuticals, North America LLC, Bridgewater, NJ 08807.

## Reason for recall

CGMP Deviations: products manufactured under conditions that could impact its product quality.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0055-2019
- **Recalling firm:** Product Quest Manufacturing LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-03
- **Report date:** 2018-10-24
- **Termination date:** 2021-03-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Daytona Beach, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0055-2019

## Citation

> AI Analytics. FDA recall D-0055-2019. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-0055-2019. Source: US FDA. Licensed CC0.

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