FDA-Drug2018-10-24Class II
Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431.
Product Quest Manufacturing LLC
Hazard
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Sold states
Nationwide in the USA
Affected count
102,348 bottles
Manufactured in
330 Carswell Ave, N/A, Daytona Beach, FL, United States
Products
Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0048-2019Don't want to check this manually?
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