CGMP Deviations: products manufactured under conditions that could impact its product quality.
Drugs Recalls
Prescription and over-the-counter medications
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 41854 3.
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9.
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 g) can, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, UPC 7 13733 27615 3.
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories, Inc., Atlanta, GA 30339.
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341
Product Quest Manufacturing
Superpotent Drug: high out of specification assay results for the menthol 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.
CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.
Product Quest Manufacturing
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL) bottle, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072, UPC 7 27510 00373 3 .
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
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.
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7.
Product Quest Manufacturing
Failed Stability Specifications: separation of product and failure for actives.
Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1.
Product Quest Manufacturing
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3.
Product Quest Manufacturing
Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
CGMP Deviations: products manufactured under conditions that could impact its product quality.