October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distri
Hazard: Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain
Hazard: Superpotent Drug: high out of specification assay results for the menthol ingredient.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin
Hazard: Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed by: Expedite Products, Inc., Tam
Hazard: Superpotent Drug: high out of specification assay results for the camphor ingredient.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miam
Hazard: Failed Stability Specifications: separation of product and failure for actives.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour +
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Streng
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Walgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Extra Moisturizing, 12 Hour, 0.5 F
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour, 0.75 FL OZ (22 mL) bottl
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Best Choice, 12 Hour No-Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle,
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) b
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochloride 0.05%), Nasal Decongestant, 1 FL OZ (3
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 0
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distribute
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery Elm, 3 FL OZ (89 mL) can, Distributed By:
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazoline hydrochloride 0.05%), 12 Hour, 1 FL OZ (3
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 mL
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed by C.D.M.A., Inc., 43157 W. Ni
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 4
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Dist
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Premier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride) Solution, 4.25 FL OZ (126 mL)
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Premier Value, Nasal Decongestant, No Drip Nasal Spray (oxymetazoline HCl) Nasal Solution, 12 Hour Pump Mist, Maximum St
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distr
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., D
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 g) can, Dist. By Meijer Distribution, In
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b) 3FL OZ (8
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ (44 mL) bottle UPC 7 27510 005
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.