The Recall Desk

FDA (Drugs) recall action 78669

Intrathecal Compounding Specialist, LLC recalled 4 products on 2018-02-14

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
2018-02-14
Critical
0
Units
—

Why these products were recalled

Lack of sterility assurance.

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

1–4 of 4

  • SevereFDA (Drugs)··2018-02-14

    FDA Recalls Sufentanil Citrate Preparations Due to Sterility Concerns

    The FDA is recalling sterile drug preparations made from Sufentanil Citrate Base Solution due to a lack of sterility assurance. The products were compounded by Intrathecal Compounding Specialists.

    Product
    All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-02-14

    FDA Recalls Sterile Morphine Sulfate Preparations Due to Sterility Concerns

    Intrathecal Compounding Specialist, LLC is recalling sterile morphine sulfate preparations compounded between October 16 and November 17, 2017, due to a lack of sterility assurance.

    Product
    All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-02-14

    FDA Recalls Fentanyl Citrate Sterile Drug Preparations for Sterility Concerns

    Intrathecal Compounding Specialist, LLC is recalling sterile drug preparations made from Fentanyl Citrate Base Solution due to a lack of sterility assurance.

    Product
    All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-02-14

    FDA Recalls Hydromorphone Sterile Drug Preparations for Lack of Sterility Assurance

    Intrathecal Compounding Specialist is recalling sterile drug preparations made from Hydromorphone Base Solution due to a lack of sterility assurance.

    Product
    All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
    Category
    Distribution
    0 states