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FDAAugust 10, 2018drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

remedyrepack

UPCs

61786079119

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear