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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 8181–8200 of 17,773 recalls

Class IIOngoing

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

Teva Pharmaceuticals USA

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

November 27, 2018 · DrugView details →

Class IIOngoing

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

Teva Pharmaceuticals USA

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

November 27, 2018 · Drug

View details →

Class IIITerminated

Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40

Glenmark Pharmaceuticals Inc., USA

Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.

November 27, 2018 · DrugView details →

Class IITerminated

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.

Tris Pharma Inc.

Superpotent Drug: recalled lots may have higher concentration of ibuprofen.

November 26, 2018 · DrugView details →

Class IITerminated

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.

Tris Pharma Inc.

Superpotent Drug: recalled lots may have higher concentration of ibuprofen.

November 26, 2018 · DrugView details →

Class IITerminated

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3.

Tris Pharma Inc.

Superpotent Drug: recalled lots may have higher concentration of ibuprofen.

November 26, 2018 · DrugView details →

Class IIITerminated

Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05

QuVa Pharma, Inc.

Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

November 21, 2018 · DrugView details →

Class IITerminated

Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408

AVKARE Inc.

Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product

November 20, 2018 · DrugView details →

Class IIOngoing

Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.

Mylan Pharmaceuticals Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

November 20, 2018 · DrugView details →

Class IIOngoing

Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.

Mylan Pharmaceuticals Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

November 20, 2018 · DrugView details →

Class IIOngoing

Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93.

Mylan Pharmaceuticals Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

November 20, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77.

Mylan Pharmaceuticals Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

November 20, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.

Mylan Pharmaceuticals Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

November 20, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77.

Mylan Pharmaceuticals Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

November 20, 2018 · DrugView details →

Class IIOngoing

Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.

Mylan Pharmaceuticals Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

November 20, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5813-77.

Mylan Pharmaceuticals Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

November 20, 2018 · DrugView details →

Class IITerminated

Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10

Pharm D Solutions, LLC

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

November 19, 2018 · DrugView details →

Class IITerminated

SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304

CAO Group, Inc.

cGMP violations noted during the firm's most recent inspection.

November 16, 2018 · DrugView details →

Class IITerminated

fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105

CAO Group, Inc.

cGMP violations noted during the firm's most recent inspection.

November 16, 2018 · DrugView details →

Class IITerminated

FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003

CAO Group, Inc.

cGMP violations noted during the firm's most recent inspection.

November 16, 2018 · DrugView details →

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