The Recall Desk

FDA (Drugs) recall action 76873

Medisca, Inc. recalled 4 products on 2017-04-19

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2017-04-19
Critical
0
Units
—

Why these products were recalled

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

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

1–4 of 4

  • ModerateFDA (Drugs)··2017-04-19

    Medisca Recalls Estriol USP Bulk Due to cGMP Deviations

    Medisca, Inc. is recalling Estriol, USP (Micronized) Bulk in various bottle sizes due to cGMP deviations identified during an FDA inspection.

    Product
    ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-04-19

    Medisca Recalls Estrone USP Bulk Due to cGMP Deviations

    Medisca, Inc. is recalling Estrone, USP Bulk in various bottle sizes due to current Good Manufacturing Practice (cGMP) deviations identified during an FDA inspection.

    Product
    ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-04-19

    Medisca Recalls Estradiol Bulk Due to cGMP Deviations

    Medisca, Inc. is recalling Estradiol, USP Bulk (Hemihydrate) in 25 g and 100 g bottles due to cGMP deviations identified during an FDA inspection.

    Product
    ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-04-19

    Medisca Recalls Estradiol API Due to cGMP Deviations

    Medisca, Inc. is recalling Estradiol, USP (Hemihydrate) (Micronized) API products due to cGMP deviations identified during a recent FDA inspection.

    Product
    ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09)
    Category
    Distribution
    0 states