FDA (Drugs) recall action 80750
The FDA (Drugs) publishes a recall like this one as 54 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 54 pages.
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Superpotent Drug: high out of specification assay results for the camphor ingredient.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Product Quest Manufacturing LLC is recalling CVS-branded Sinus Relief nasal spray due to failed microbiological testing for Pseudomonas aeruginosa.
Product Quest Manufacturing LLC is recalling 10,584 cans of Premier Value Sterile Saline Nasal Mist due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling Rhinall Nasal Decongestant Nasal Spray due to manufacturing conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling Rhinall nasal drops due to CGMP deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling 552 bottles of CVS Health Saline Nasal Spray due to CGMP deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling Rite Aid nasal spray due to manufacturing conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling QC Quality Choice Saline Nasal Gel with Soothing Aloe due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling CVS Health Sterile Saline Nasal Mist due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling 786,720 bottles of DG Health No Drip Nasal Pump Mist due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling Freeze It spray cans due to high out-of-specification camphor levels.
Product Quest Manufacturing LLC is recalling Mushatt's No. 9 PsoriWash Medicated Wash due to microbial contamination and low salicylic acid levels.
Product Quest Manufacturing LLC is recalling Meijer Saline Nasal Spray because it was manufactured under conditions that could impact product quality.
Product Quest Manufacturing is recalling Thayers Saline Nasal Mist due to manufacturing conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling Harmon Face Values Saline Nasal Spray due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling CVS Health Baby Nasal Spray/Drops due to manufacturing conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling CVS Health Saline Nasal Gel with Soothing Aloe due to manufacturing conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling 6,516 tubes of Well at Walgreens Scar Cream with SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.
Product Quest Manufacturing LLC is recalling Walgreens Nasal Spray (Oxymetazoline HCl 0.05%) due to CGMP deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling Best Choice 12 Hour Sinus Relief Nasal Spray because it was manufactured under conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling 9,480 tubes of Dr. Brandt BB Cream with SPF 30 due to failed stability specifications, including product separation.
Product Quest Manufacturing LLC is recalling Walgreens NO DRIP Severe Anefrin Nasal Spray due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling Best Choice Nasal Spray because it was manufactured under conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling Dermatone No-Touch Sunscreen Sticks because samples tested positive for Staphylococcus aureus.
Product Quest Manufacturing LLC is recalling QC Quality Choice Saline Nasal Spray due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling Cicatricure Scar Cream + Sunscreen SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.