Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 5 mg/160 mg because FDA testing confirmed the presence of 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 recall is classified as FDA Class II and involves the presence of NDEA, a known carcinogenic impurity, which meets the rubric criteria for a Severe rating.
Plain-English summary
Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 5 mg/160 mg, available in 30-count and 90-count bottles. The recall involves 120,394 bottles distributed nationwide in the United States, including Puerto Rico. The affected products are identified by NDC 0093-7690-56 and NDC 0093-7690-98, and include lot numbers 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, and 23X024.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) in the product. The agency has classified this recall as Class II.
Consumers who have these specific bottles should stop using the medication and contact their healthcare provider or pharmacist for guidance on alternative treatments. The product was manufactured in Israel by Teva Pharmaceutical Ind. Ltd. for Teva Pharmaceuticals USA, Inc.
The recalled product
- Product
- Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales,
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 120,394
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 0093-7690-56 & NDC 0093-7690-98 Lot # 23X017
- 23X018
- 23X019
- 23X020
- 23X022
- 23X023
- 23X024
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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