Agency classClass IIOur severity:Severe FDA (Drugs)·D-0984-2018·Announced 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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a carcinogen impurity in a prescription drug, which constitutes a significant health risk. Per the rubric, FDA Class II recalls involving significant injury or serious health risks are classified as Severe.

Plain-English summary

Teva Pharmaceuticals USA is recalling 64,168 bottles of Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg, 90-count. The affected product is distributed by Actavis Pharma, Inc., and was manufactured by Arrow Pharma (Malta) Ltd. in India. The recall covers specific lot numbers: 1191185M, 1191186M, 1225615M, 1233948M, 1250718M, and 1253257M.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product. The agency has classified this recall as Class II.

The product was distributed throughout the United States, including Hawaii and Puerto Rico. Patients and healthcare providers should check their medication bottles for the affected NDC (0591-2318-19) and lot numbers listed above. If the medication matches the recalled lots, patients should contact their healthcare provider for guidance on alternative treatment options.

The recalled product

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
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Prescription Medication
Hazard: carcinogen-impurity
cgmp-deviation
Affected units: 64,168

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Lot Numbers: 1191185M
1191186M
1225615M
1233948M
1250718M
1253257M

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 9 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

See all →

Moderate
Doxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
Low
Prescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
Moderate
Tretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
Low
Mimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
Moderate
Brinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26

Same hazard · carcinogen impurity