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.
Reported: October 24, 2018 Initiated: August 3, 2018 #D-0055-2019
Product Description
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.
Details
- Recalling Firm
- Product Quest Manufacturing LLC
- Units Affected
- 3,442,536 bottles
- Distribution
- Nationwide in the USA
- Location
- Daytona Beach, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Product Quest Manufacturing LLC. Units affected: 3,442,536 bottles.
Why was this product recalled? ▼
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 24, 2018. Severity: Moderate. Recall number: D-0055-2019.
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