Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Teva Pharmaceuticals USA is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).
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 agency classification is FDA Class II, and the presence of NDEA, a potential carcinogen, in a prescription drug constitutes a significant health risk warranting a Severe rating under the rubric.
Plain-English summary
Teva Pharmaceuticals USA is recalling 41,572 bottles of Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg. The affected products are available in 30-count bottles (NDC 0093-7807-56) and 90-count bottles (NDC 0093-7807-98). The specific lots involved are 18X010 and 18X011.
The recall was initiated because FDA laboratory testing confirmed the presence of an impurity, N-nitrosodimethylamine (NDEA), in the product. This finding represents a Current Good Manufacturing Practice (CGMP) deviation.
The affected products were distributed nationwide in the United States, including Puerto Rico. Patients and consumers should check their medication bottles for the specific NDC and lot numbers listed above. If the medication matches the recalled description, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMA
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Affected units
- 41,572
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 (2)
- NDC 0093-7807-56 & 0093-7807-98 Lot # 18X010
- 18X011
Distribution
Part of a larger recall action
This product is one of 8 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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