The Recall Desk

FDA (Drugs) recall action 80006

Mylan Pharmaceuticals Inc. recalled 3 products on 2018-05-30

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
2018-05-30
Critical
0
Units
—

Why these products were recalled

CGMP Deviations

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

States named across these recalls

1–3 of 3

  • ModerateFDA (Drugs)··2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Orally Disintegrating Tablets

    Mylan Pharmaceuticals Inc. is voluntarily recalling PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets due to CGMP deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is voluntarily recalling specific lots of Prednisolone Sodium Phosphate tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is voluntarily recalling specific lots of Prednisolone Sodium Phosphate Orally Disintegrating Tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
    Category
    Distribution
    1 state