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 Premier Value Fast Relief Muscle Rub because the menthol ingredient exceeded specification limits.
Product Quest Manufacturing LLC is recalling 3,600 bottles of Best Choice Nasal Spray because they were manufactured under conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling CVS Health Triple Antibiotic Ointment Spray because the bacitracin zinc ingredient was found to be subpotent.
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 TopCare Saline Nasal Gel with Soothing Aloe due to manufacturing conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling Premier Value Nasal Decongestant Nasal Spray because it was manufactured under conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling Best Choice Saline Nasal Spray because it was manufactured under conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling Meijer Sterile Saline Nasal Mist cans due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling 46,056 cans of FAMILY wellness Sterile Saline Nasal Mist because they were manufactured under conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling Rexall Extra Moisturizing No Drip Nasal Spray due to manufacturing conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling Rite Aid First Aid Antibiotic Ointment because the bacitracin zinc ingredient was found to be subpotent.
Product Quest Manufacturing LLC is recalling Premier Value Nasal Decongestant due to CGMP deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling Premier Value Saline Nasal Spray due to manufacturing 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 HuMist Saline Nasal Mist bottles due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling CeraVe Healing Lip Balm/SPF 30 due to failed microbiological testing for Staphylococcus aureus.
This FDA drug recall affects Walgreens NO DRIP Anefrin nasal spray due to current good manufacturing practice deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling Harmon Face Values Saline Nasal Gel with Soothing Aloe due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray because it was manufactured under conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling Well at Walgreens ULTRA FINE Sinus Relief Mist due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling Family Dollar Saline Nasal Spray due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling Rexall Sinus Nasal Pump Mist due to manufacturing deviations that could impact product quality.
Product Quest Manufacturing LLC is recalling Rexall Extra Moisturizing No Drip Nasal Spray due to CGMP deviations that could impact product quality.
Product Quest Manufacturing is recalling Thayers Saline Nasal Spray due to manufacturing conditions that could impact product quality.
Product Quest Manufacturing LLC is recalling Finafta Baby Oral Gel because it was manufactured under conditions that could impact product quality.