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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 8541–8560 of 17,773 recalls

Class IITerminated

Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.

Product Quest Manufacturing LLC

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

August 3, 2018 · DrugView details →

Class IITerminated

TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.

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, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Product #282472, 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 ITerminated

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-158-04.

Westminster Pharmaceuticals LLC

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

August 3, 2018 · DrugView details →

Class IITerminated

Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.

Product Quest Manufacturing LLC

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

August 3, 2018 · DrugView details →

Class ITerminated

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-157-04.

Westminster Pharmaceuticals LLC

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

August 3, 2018 · DrugView details →

Class IIITerminated

Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.

Product Quest Manufacturing LLC

Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.

August 3, 2018 · DrugView details →

Class ITerminated

Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.

Product Quest Manufacturing LLC

Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.

August 3, 2018 · DrugView details →

Class IITerminated

Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3.

Product Quest Manufacturing LLC

Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.

August 3, 2018 · DrugView details →

Class IITerminated

QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 mL) bottle UPC 6 35515 98845 3; b) 3 FL OZ (89 mL) bottle UPC 6 35515 95042 9, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995.

Product Quest Manufacturing LLC

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

August 3, 2018 · DrugView details →

Class IITerminated

Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ (44 mL) bottle UPC 7 27510 00501 0; b) 3 FL OZ (88 mL) bottle UPC 7 27510 00502 7, Distributed by Harmon Stores, Inc., Union, NJ 07083 USA.

Product Quest Manufacturing LLC

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

August 3, 2018 · DrugView details →

Class IITerminated

meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b) 3FL OZ (88 mL) UPC 7 08820 74430 1, Dist. By Meijer Distribution, Inc., Grand Rapids, MI 49544 .

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 Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7001-01, UPC 3 11917 18536 1.

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, 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 LLC

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

August 3, 2018 · DrugView details →

Class IITerminated

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 LLC

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

August 3, 2018 · DrugView details →

Class IITerminated

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 LLC

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

August 3, 2018 · DrugView details →

Class IITerminated

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 LLC

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

August 3, 2018 · DrugView details →

Class IITerminated

CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Benzalkonium Chloride as Preservatives, 1.5 FL OZ (44 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 40814 8 Product #891465.

Product Quest Manufacturing LLC

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

August 3, 2018 · DrugView details →

Class IITerminated

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 LLC

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

August 3, 2018 · DrugView details →

Class IITerminated

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 LLC

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

August 3, 2018 · DrugView details →

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