The Recall Desk

FDA (Drugs) recall action 84233

Golden State Medical Supply Inc. recalled 2 products on 2019-11-20

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-11-20
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··2019-11-20

    GSMS Recalls Ranitidine Capsules Due to NDMA Impurity Detection

    Golden State Medical Supply Inc. is recalling specific lots of Ranitidine Capsules 150 mg because the FDA detected the NDMA impurity in the product.

    Product
    GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
    Category
    Distribution
    4 states
  • SevereFDA (Drugs)··2019-11-20

    GSMS Recalls Ranitidine Capsules Due to NDMA Impurity Detection

    Golden State Medical Supply Inc. is recalling specific lots of Ranitidine Capsules 300 mg because the FDA detected the NDMA impurity in the product.

    Product
    GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
    Category
    Distribution
    4 states