FDAFDA · Food and drugs·Recall number D-1553-2014
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, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02
Published August 27, 2014 · Recall initiated: June 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Healix Infusion Therapy, Inc.
- Distributor
- Texas and Georgia
- Lot
- Lot 7250-0 Exp. 08/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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