US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Aug 17, 2018 (8 years ago)

Amlodipine

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

Why it was recalled

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

What was recalled

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30

Recalling firm
Torrent Pharma Inc.
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1144-2018

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