The Recall Desk

FDA (Drugs) recall action 80748

A-S Medication Solutions LLC. recalled 4 products on 2018-08-29

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2018-08-29
Critical
0
Units
1,899

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.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • SevereFDA (Drugs)··2018-08-29

    A-S Medication Solutions Recalls Valsartan and Hydrochlorothiazide Tablets

    A-S Medication Solutions LLC is recalling 531 bottles of Valsartan and Hydrochlorothiazide Tablets due to the detection of a carcinogen impurity in the active pharmaceutical ingredient.

    Product
    Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-08-29

    A-S Medication Solutions Recalls Valsartan and Hydrochlorothiazide Tablets

    A-S Medication Solutions LLC is recalling Valsartan and Hydrochlorothiazide Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-08-29

    A-S Medication Solutions Recalls Valsartan Tablets Due to Carcinogen Impurity

    A-S Medication Solutions LLC is recalling Valsartan Tablets 160 MG because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-08-29

    A-S Medication Solutions Recalls Valsartan Tablets Due to Carcinogen Impurity

    A-S Medication Solutions LLC is recalling 178 bottles of Valsartan Tablets, 80 MG, because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
    Category
    Distribution
    0 states