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FDAAugust 24, 2018drug

Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00

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

The hazard

CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.

What to do

FDA enforcement status: Terminated

Brands named

remedyrepack

UPCs

7051812200013668032530

Recall history

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

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Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00 — Recall Details · AllClear