Product Quest Manufacturing LLC recalls 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 0
Recalled October 24, 2018 · FDA recall D-0055-2019 · Product Quest Manufacturing
Hazard
CGMP Deviations: products manufactured under conditions that could impact its product quality. · FDA Class II
Units
3,442,536 bottles
Sold at
Nationwide in the USA
Description
CGMP Deviations: products manufactured under conditions that could impact its product quality.
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.
Manufacturer(s)
Product Quest Manufacturing LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →