The Recall Desk

FDA (Drugs) recall action 72967

Amerita Specialty Infusion Services recalled 2 products on 2016-01-27

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
2016-01-27
Critical
0
Units
2

Why these products were recalled

Lack of Assurance of Sterility

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Drugs)··2016-01-27

    Amerita Recalls Baclofen and Clonidine Syringes Due to Sterility Concerns

    Amerita Specialty Infusion Services is recalling specific lots of compounded intrathecal syringes because the company cannot ensure they are sterile.

    Product
    IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-01-27

    Amerita Recalls Baclofen Syringes Due to Sterility Assurance Concerns

    Amerita Specialty Infusion Services is recalling specific lots of compounded Baclofen syringes because the FDA identified a lack of assurance of sterility.

    Product
    Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
    Category
    Distribution
    0 states