The Recall Desk

FDA (Drugs) recall action 80646

RemedyRepack Inc. recalled 2 products on 2018-08-08

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-08-08
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··2018-08-08

    RemedyRepack Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling specific lots of Valsartan/HCTZ tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2018-08-08

    RemedyRepack Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan/HCTZ 160 mg/12.5 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
    Category
    Distribution
    1 state