Drug product
0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 720ML, used with Curlin pump, no pump or gravity. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
D-0272-2023
Product summary
- Event
- Event 91466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 114 bags total
- Official record key
drug-enforcement:D-0272-2023
Official wording
Reason: Lack of sterility assurance
Code information: Beyond Use date December 24 - December 31, 2022
Distribution pattern: Dispensed to Patients Nationwide.
Derived failure modes
-
Sterility assurance
Lack of sterility