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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 8561–8580 of 17,773 recalls

Class IITerminated

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 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Division of Valeant Pharmaceuticals, North America LLC, Bridgewater, NJ 08807.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IIITerminated

Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02

Huijing (Shanghai) Bio-tech Co., Ltd.

Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.

August 3, 2018 · Drug

View details →

Class IITerminated

CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Product #282476; and b) Net Wt. 0.5 OZ tube (14.2 g) UPC 0 50428 31746 4 Product #896071; Distributed by CVS Pharmacy, Inc,. One CVS Drive, Woonsocket, RI 02895.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

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 LLC

Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.

August 3, 2018 · DrugView details →

Class IITerminated

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 LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

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 LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

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 LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

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 LLC

Failed Stability Specifications: separation of product and failure for actives.

August 3, 2018 · DrugView details →

Class IITerminated

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 LLC

Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.

August 3, 2018 · DrugView details →

Class IITerminated

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 LLC

Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.

August 3, 2018 · DrugView details →

Class IITerminated

Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Strength, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015,NDC 0363-7005-01, UPC 3 11917 18537 8.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour, 0.75 FL OZ (22 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, UPC 3 11917 18622 1.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, packaged as a) 3 FL OZ (89 mL) bottle UPC 0 93351 01833 6; b) 1.5 FL OZ (45 mL) bottle UPC 0 93351 01834 3, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed by: Expedite Products, Inc., Tampa, FL 33619 USA, UPC 8 56569 00203 6.

Product Quest Manufacturing LLC

Superpotent Drug: high out of specification assay results for the camphor ingredient.

August 3, 2018 · DrugView details →

Class IITerminated

Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery Elm, 3 FL OZ (89 mL) can, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00659 8.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

Premier Value, Nasal Decongestant, No Drip Nasal Spray (oxymetazoline HCl) Nasal Solution, 12 Hour Pump Mist, Maximum Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-308-03, UPC 8 40986 01519 9.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 29380 5 Product #459367.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co,. 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 63684 7.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

Walgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Extra Moisturizing, 12 Hour, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7004-01, UPC 3 11917 18534 7.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

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