US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 15, 2018 (8 years ago)

Valsartan Tablets USP 320 mg

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

Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9

Recalling firm
Preferred Pharmaceuticals, Inc
NDC code
68788-6882-9
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1107-2018

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.

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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