FDA (Drugs) recall action 80538

Teva Pharmaceuticals USA recalled 9 products on 2018-08-01

The FDA (Drugs) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2018-08-01
Critical: 0
Units: 580,481

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–9 of 9

SevereFDA (Drugs)··2018-08-01
Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
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.
Category
Distribution
2 states
SevereFDA (Drugs)··2018-08-01
Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
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.
Category
Distribution
2 states
SevereFDA (Drugs)··2018-08-01
Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API
Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 320 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
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.
Category
Distribution
2 states
SevereFDA (Drugs)··2018-08-01
Teva Recalls Valsartan Tablets Due to Carcinogen Impurity
Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 80 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
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
Category
Distribution
2 states
SevereFDA (Drugs)··2018-08-01
Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API
Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
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
Category
Distribution
2 states
SevereFDA (Drugs)··2018-08-01
Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API
Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 40 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
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
Category
Distribution
2 states
SevereFDA (Drugs)··2018-08-01
Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Teva Pharmaceuticals is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
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.
Category
Distribution
2 states
SevereFDA (Drugs)··2018-08-01
Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
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.
Category
Distribution
2 states
SevereFDA (Drugs)··2018-08-01
Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
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
Category
Distribution
2 states