FDAFDA · Food and drugs·Recall number D-0055-2019
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.
Published October 24, 2018 · Recall initiated: August 3, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: products manufactured under conditions that could impact its product quality.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Product Quest Manufacturing LLC
- Distributor
- Nationwide in the USA
- Lot
- All lots remaining within expiry.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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