Agency classClass IIOur severity:Severe FDA (Drugs)·D-0987-2018·Announced 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.

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 is classified as FDA Class II and involves a carcinogen impurity, which poses a significant health risk and aligns with the 'Severe' criteria for significant injury or serious health concerns.

Plain-English summary

Teva Pharmaceuticals USA is voluntarily recalling specific lots of Valsartan Tablets, USP 80 mg. The recall involves 90-count and 1,000-count bottles distributed throughout the United States, including Hawaii and Puerto Rico. The affected products were manufactured by Arrow Pharma (Malta) Ltd. in India and distributed by Actavis Pharma, Inc.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, a carcinogen impurity was detected in the active pharmaceutical ingredient (API) used to manufacture the drug product. The source text does not provide specific details on the type of carcinogen or the concentration levels.

Consumers who have these specific lot numbers should stop using the medication and consult their healthcare provider for alternative treatment options. The affected lot numbers are 1175947M, 1175948M, 1177115A, 1219361A, 1240434M, 1250704M for the 90-count bottles, and 1177114A, 1219360M, 1250706A for the 1,000-count bottles.

The recalled product

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
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Antihypertensive
Hazard: carcinogen-impurity
cgmp-deviation

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 (8)

Lot Numbers: NDC 0591-2168-19 1175947M
1175948M
1177115A
1219361A
1240434M
1250704M NDC 0591-2168-10 1177114A
1219360M
1250706A

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 →

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