The Recall Desk

FDA (Drugs) recall action 81458

Sciegen Pharmaceuticals Inc recalled 6 products on 2018-11-28

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2018-11-28
Critical
0
Units
66,816

Why these products were recalled

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in 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.

1–6 of 6

  • SevereFDA (Drugs)··2018-11-28

    Sciegen Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling Irbesartan 300mg tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in…
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 75 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 150 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, USP, 300 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-11-28

    Sciegen Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling Westminister Irbesartan Tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in…
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling Irbesartan Tablets, 150 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made…
    Category
    Distribution
    0 states