The Recall Desk

FDA (Drugs) recall action 90992

Golden State Medical Supply Inc. recalled 2 products on 2022-10-26

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
2022-10-26
Critical
0
Units
—

Why these products were recalled

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

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

1–2 of 2

  • HighFDA (Drugs)··2022-10-26

    Rifampin Capsules recalled due to excessive impurity levels

    Golden State Medical Supply Inc. is recalling Rifampin Capsules, USP, 300 mg, because samples exceeded acceptable limits for 1-Methyl-4-Nitrosopoperazine (MNP), an impurity. Multiple lot numbers were distributed nationwide.

    Product
    Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-10-26

    Rifampin Capsules recalled due to excess nitrosamine impurity

    Golden State Medical Supply Inc. is recalling Rifampin Capsules, 150 mg, due to elevated levels of 1-Methyl-4-Nitrosopiperazine (MNP) exceeding the FDA interim specification limit of 5 ppm. Affected lots are distributed nationwide.

    Product
    Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30
    Category
    Distribution
    0 states