Premier Value recalled over manufacturing violations
- Recall date
- August 3, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Product Quest Manufacturing LLC recalls Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Dis…
- Recall number
- D-0047-2019
- FDA classification
- Class II
- Brand / firm
- Product Quest Manufacturing LLC
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-316-03, UPC 8 40986 01516 8.
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