Drug 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, Texas, 77478 NDC 75901-8008-33
D-1554-2014
Product summary
- Event
- Event 69056
- Status
- Terminated
- Classification
- Class II
- Quantity
- 220 syringes
- Official record key
drug-enforcement:D-1554-2014
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: Lots 7083-0, 7202-0, 7222-0 Exp. 08/14
Distribution pattern: Texas and Georgia
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility