Reported Oct 24, 2018 · Terminated
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…
Product Quest Manufacturing LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Product Quest Manufacturing LLC · 330 Carswell Ave · Daytona Beach, FL · 32117-4416
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9 |
| 2 | 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3 |
| 3 | 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. |
- Lot codes and dates
- All lots remaining within expiry.
- Amount recalled
- 3,442,536 bottles
This recall covers 54 products
The agency filed one notice per product. You are reading one of them; the other 53 are below.
41 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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