The Recall Desk

FDA (Drugs) recall action 81500

Golden State Medical Supply Inc. recalled 3 products on 2018-11-28

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
2018-11-28
Critical
0
Units
30,858

Why these products were recalled

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (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.

1–3 of 3

  • SevereFDA (Drugs)··2018-11-28

    Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity

    Golden State Medical Supply is recalling 12,502 bottles of Irbesartan 300 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).

    Product
    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: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-11-28

    FDA Recalls Irbesartan Tablets Due to NDEA Impurity

    Golden State Medical Supply Inc. is recalling 2,439 bottles of Irbesartan 75 mg tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

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

    Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity

    Golden State Medical Supply is recalling Irbesartan 150 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).

    Product
    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: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
    Category
    Distribution
    0 states