Valsartan 80 mg Tablet recalled over manufacturing violations

Recall date

August 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

RemedyRepack Inc. recalls Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4,…

Recall number

D-1100-2018

FDA classification

Class II

Brand / firm

RemedyRepack Inc.

Sold / distributed

Product was distributed to three customers in FL and VA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19