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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 8601–8620 of 17,793 recalls

Class IITerminated

CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Landover, MD 20785, 1-877-846-9949, UPC 3 41520 00175 8.

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 Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 7 .

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 No-Drip 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 59895 4.

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), 1/4 grain (15 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-159-04.

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

Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-304-03, UPC 8 40986 01518 2.

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, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL OZ (44 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 58487 2.

Product Quest Manufacturing LLC

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

August 3, 2018 · DrugView details →

Class IITerminated

Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 4.

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, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride) Solution, 4.25 FL OZ (126 mL) can, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 8 40986 02998 1.

Product Quest Manufacturing LLC

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

August 3, 2018 · DrugView details →

Class IITerminated

Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazoline hydrochloride 0.05%), 12 Hour, 1 FL OZ (30 mL) bottle, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 31412 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, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29525 0.

Product Quest Manufacturing LLC

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

August 3, 2018 · DrugView details →

Class ITerminated

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-155-04.

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

Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30 mL) bottle, Distributed by: Scherer Labs International, LLC., 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02747 52531 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, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, Product #277790.

Product Quest Manufacturing LLC

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

August 3, 2018 · DrugView details →

Class IITerminated

Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Pharmcore Inc.

Lack of assurance of sterility.

August 2, 2018 · DrugView details →

Class IITerminated

Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Pharmcore Inc.

Lack of assurance of sterility.

August 2, 2018 · DrugView details →

Class IITerminated

Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Pharmcore Inc.

Lack of assurance of sterility.

August 2, 2018 · DrugView details →

Class IITerminated

Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Pharmcore Inc.

Lack of assurance of sterility.

August 2, 2018 · DrugView details →

Class IITerminated

Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Pharmcore Inc.

Lack of assurance of sterility.

August 2, 2018 · DrugView details →

Class IITerminated

Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Pharmcore Inc.

Lack of assurance of sterility.

August 2, 2018 · DrugView details →

Class IITerminated

Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Pharmcore Inc.

Lack of assurance of sterility.

August 2, 2018 · DrugView details →

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