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.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe severity score under the rubric, particularly given the detection of a carcinogen impurity.
Plain-English summary
Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets, USP 40 mg, in 30-count and 90-count bottles. The recall is 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 affected products are manufactured by Arrow Pharma (Malta) Ltd. in India and distributed by Actavis Pharma, Inc. in Parsippany, NJ. The recall includes 8,046 30-count bottles and 20,841 90-count bottles. The specific lot numbers are 1196936A, 1238463A, and 1270617A for the 30-count bottles (NDC 0591-2167-30), and 1196934M, 1238462M, and 1268429A for the 90-count bottles (NDC 0591-2167-19).
The product was distributed throughout the United States, including Hawaii and Puerto Rico. Consumers and healthcare providers should check their medication for these specific NDC and lot numbers. If the medication matches the recalled lots, patients should contact their healthcare provider for guidance on alternative treatment options.
The recalled product
- 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
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
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 (5)
- Lot Numbers: NDC 0591-2167-30 1196936A
- 1238463A
- 1270617A NDC 0591-2167-19 1196934M
- 1238462M
- 1268429A
Distribution
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.
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