The Recall Desk

FDA (Drugs) recall action 80827

RemedyRepack Inc. recalled 3 products on 2018-08-22

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2018-08-22
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

1–3 of 3

  • SevereFDA (Drugs)··2018-08-22

    RemedyRepack Recalls Valsartan 80 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the product.

    Product
    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
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··2018-08-22

    RemedyRepack Recalls Valsartan 160 mg Tablets Due to Carcinogen Impurity

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

    Product
    Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··2018-08-22

    RemedyRepack Recalls Valsartan 320 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling specific lots of Valsartan 320 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19
    Category
    Distribution
    2 states