The Recall Desk

FDA (Drugs) recall action 75964

Apotex Corp. recalled 2 products on 2017-01-11

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
2017-01-11
Critical
0
Units
—

Why these products were recalled

CGMP Deviations

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

1–2 of 2

  • ModerateFDA (Drugs)··2017-01-11

    Apotex Recalls Torsemide Tablets Due to Manufacturing Deviations

    Apotex Corp. is voluntarily recalling Torsemide Tablets 20 mg due to CGMP deviations. The recall covers 35,819 bottles distributed in the United States.

    Product
    Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-01-11

    Apotex Recalls Torsemide Tablets Due to Manufacturing Deviations

    Apotex Corp. is voluntarily recalling Torsemide Tablets, 5 mg, due to Current Good Manufacturing Practice (CGMP) deviations. The recall covers 13,179 bottles distributed in the United States.

    Product
    Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01
    Category
    Distribution
    0 states