Product Quest Manufacturing Premier Value, Nasal Decongestant, Nasal Spray recall — FDA D-0047-2019
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Overview of recall records associated with Product Quest Manufacturing LLC, including dates, categories and classifications where available.
Classification mix: Class II: 43, Class III: 2, Class I: 1.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Superpotent Drug: high out of specification assay results for the camphor ingredient.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
This page summarizes recall records in which the official source identifies Product Quest Manufacturing LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.