The Recall Desk

FDA (Drugs) recall action 63511

New England Compounding Center 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

GMP Deviations

Lack of Assurance of Sterility

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

1–2 of 2

  • SevereFDA (Drugs)··2012-11-21

    New England Compounding Center Recalls Non-Sterile Products Due to GMP Deviations

    New England Compounding Center is voluntarily recalling all non-sterile products due to Good Manufacturing Practice (GMP) deviations. The recall covers products distributed nationwide and in Japan.

    Product
    All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-11-21

    Sterile Products from New England Compounding Center Recalled Due to Sterility Concerns

    New England Compounding Center is recalling all of its sterile products because the company cannot assure that the products are sterile.

    Product
    All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
    Category
    Distribution
    0 states