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.
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, and the presence of a carcinogen impurity in a prescription drug represents a significant health risk, aligning with the 'Severe' criteria for significant injury or high-risk contamination.
Plain-English summary
Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets, USP 160 mg, in 90-count and 1000-count bottles. 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 affected products are distributed throughout the United States, including Hawaii and Puerto Rico. The recall covers 15,347 90-count bottles and 8,378 1000-count bottles. The specific NDCs and lot numbers involved are NDC 0591-2169-19 (Lots 1177880A, 1220831A, 1263941A) and NDC 0591-2169-10 (Lots 1175922M, 1220826M, 1236294M, 1240427M, 1270616A).
Consumers and healthcare providers should check their inventory for these specific lot numbers and NDCs. If the product matches the recalled items, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- 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
- 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 (7)
- NDC 0591-2169-19 Lot Numbers: 1177880A
- 1220831A
- 1263941A NDC 0591-2169-10 1175922M
- 1220826M
- 1236294M
- 1240427M
- 1270616A
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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