US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Nov 27, 2018 (8 years ago)

Amlodipine and Valsartan Tablets 10 mg/320 mg

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

What was recalled

Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

Recalling firm
Teva Pharmaceuticals USA
NDC code
0093-7693-56
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0306-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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Class II · Moderate risk Ongoing

Diovan

Reason Failed Dissolution Specifications

Novartis Pharmaceuticals Corporation NDC 0078-0359-34 D-0746-2026
Class II · Moderate risk Ongoing

Valsartan Tablets 320 mg USP

Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Rising Pharmaceuticals, Inc. NDC 52343-125-90 D-1055-2019
Class II · Moderate risk Ongoing

Valsartan Tablets 160 mg USP

Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Rising Pharmaceuticals, Inc. NDC 52343-124-90 D-1054-2019
Class II · Moderate risk Ongoing

Valsartan Tablets 80 mg USP

Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Rising Pharmaceuticals, Inc. NDC 52343-123-90 D-1053-2019