US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 2, 2013 (13 years ago)

Valsartan

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

Why it was recalled

Labeling: Label Mixup: VALSARTAN, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD52372_4, EXP: 5/17/2014; ZINC SULFATE, Capsule, 50 mg, NDC 00904533260, Pedigree: AD30994_8, EXP: 5/9/2014.

What was recalled

VALSARTAN, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078042315.

Recalling firm
Aidapak Services, LLC
Origin
WA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-819-2014

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.

Other Valsartan recalls

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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