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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 9141–9160 of 17,793 recalls

Class IITerminated

Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701

RemedyRepack Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 17, 2018 · DrugView details →

Class IIOngoing

Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0

A-S Medication Solutions LLC.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 17, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

A-S Medication Solutions LLC.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 17, 2018 · DrugView details →

Class IIOngoing

Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0

A-S Medication Solutions LLC.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 17, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

A-S Medication Solutions LLC.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 17, 2018 · DrugView details →

Class IITerminated

Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701

RemedyRepack Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 17, 2018 · DrugView details →

Class IITerminated

Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY

Longbow First Aid Products Manufactory

CGMP Deviations

July 17, 2018 · DrugView details →

Class IITerminated

Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.

Longbow First Aid Products Manufactory

CGMP Deviations

July 17, 2018 · DrugView details →

Class IIOngoing

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2316-19.

Teva Pharmaceuticals USA

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 16, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054

Teva Pharmaceuticals USA

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 16, 2018 · DrugView details →

Class IIOngoing

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2317-19.

Teva Pharmaceuticals USA

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 16, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.

Teva Pharmaceuticals USA

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 16, 2018 · DrugView details →

Class IIOngoing

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19.

Teva Pharmaceuticals USA

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 16, 2018 · DrugView details →

Class IITerminated

Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89

Teva Pharmaceuticals USA

API material used in the manufacturing of the product did not receive regulatory approval prior to release.

July 16, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054

Teva Pharmaceuticals USA

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 16, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054

Teva Pharmaceuticals USA

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 16, 2018 · DrugView details →

Class IIOngoing

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19

Teva Pharmaceuticals USA

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 16, 2018 · DrugView details →

Class IIOngoing

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19.

Teva Pharmaceuticals USA

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 16, 2018 · DrugView details →

Class IIOngoing

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-313-09

Prinston Pharmaceutical Inc

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 13, 2018 · DrugView details →

Class IIOngoing

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-315-09

Prinston Pharmaceutical Inc

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 13, 2018 · DrugView details →

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