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.
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 involves a carcinogen impurity in a prescription medication, 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 99,554 bottles of Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg. The product is distributed in 90-count bottles under NDC 0591-2317-19. The affected lot numbers are 1191164M, 1191165M, 1191166M, 1191167A, 1225612M, 1250717M, 1256111M, and 1288798M.
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 for the specific NDC and lot numbers listed above. If the medication matches the recalled lots, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- 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.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Affected units
- 99,554
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: 1191164M
- 1191165M
- 1191166M
- 1191167A
- 1225612M
- 1250717M
- 1256111M
- 1288798M
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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