The Recall Desk

FDA (Drugs) recall action 82782

Heritage Pharmaceuticals, Inc. recalled 5 products on 2019-05-29

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2019-05-29
Critical
0
Units
81,873

Why these products were recalled

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

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.

1–5 of 5

  • SevereFDA (Drugs)··2019-05-29

    Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc.,
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-05-29

    Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 25 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceutical
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-05-29

    Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 50 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceutica
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-05-29

    Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceut
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-05-29

    Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 50 mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc.,
    Category
    Distribution
    0 states