Drug 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, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02
D-1553-2014
Product summary
- Event
- Event 69056
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 bags
- Official record key
drug-enforcement:D-1553-2014
Official wording
Reason: Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Code information: Lot 7250-0 Exp. 08/14
Distribution pattern: Texas and Georgia
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility