The Recall Desk

FDA (Drugs) recall action 69056

Healix Infusion Therapy, Inc. recalled 5 products on 2014-08-27

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2014-08-27
Critical
0
Units
330

Why these products were recalled

Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

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.

States named across these recalls

1–5 of 5

  • SevereFDA (Drugs)··2014-08-27

    Healix Recalls Fentanyl Infusion Bags Due to Sterility Concerns

    Healix Infusion Therapy is recalling compounded fentanyl infusion bags distributed in Texas and Georgia because the supplier recalled the source fentanyl due to loose or missing vial crimps.

    Product
    fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, S
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··2014-08-27

    Healix Recalls Fentanyl Syringes Due to Sterility Concerns

    Healix Infusion Therapy is recalling 50 fentanyl syringes because the supplier recalled the drug due to loose or missing vial crimps, raising sterility concerns.

    Product
    fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··2014-08-27

    Healix Recalls Fentanyl Infusion Bags Due to Sterility Concerns

    Healix Infusion Therapy is recalling 48 bags of compounded fentanyl in Texas and Georgia because the supplier recalled the source drug due to loose or missing vial crimps.

    Product
    fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Su
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··2014-08-27

    Healix Recalls Fentanyl Syringes Due to Sterility Concerns

    Healix Infusion Therapy is recalling 220 fentanyl prefilled syringes because the supplier recalled the drug due to loose or missing vial crimps, raising sterility concerns.

    Product
    fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··2014-08-27

    Healix Recalls Fentanyl and Ropivacaine Infusion Bags Due to Sterility Concerns

    Healix Infusion Therapy is recalling 12 bags of compounded fentanyl and ropivacaine due to a lack of assurance of sterility from a supplier recall.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at 866-299-4826,
    Category
    Distribution
    2 states