The Recall Desk

FDA (Drugs) recall action 63585

Ameridose LLC recalled 2 products on 2012-11-21

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
2012-11-21
Critical
0
Units
—

Why these products were recalled

Lack of assurance of sterility

GMP deficiencies

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

1–2 of 2

  • SevereFDA (Drugs)··2012-11-21

    Ameridose Recalls All Sterile Products Due to Sterility Assurance Concerns

    Ameridose LLC is recalling all sterile products manufactured in Westborough, MA, due to a lack of assurance of sterility. The recall is nationwide and includes all lot codes within expiry.

    Product
    All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2012-11-21

    Ameridose Recalls Non-Sterile Drug Products Due to GMP Deficiencies

    Ameridose LLC is voluntarily recalling all non-sterile products nationwide due to Good Manufacturing Practice (GMP) deficiencies. The recall was initiated in October 2012.

    Product
    All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
    Category
    Distribution
    0 states