Drug product
Sodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7ML, (e) 130ML, (f) 210ML, (g) 190ML, (h) 220ML: diluent, Rx Only, use with Curlin or Sapphire pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
D-0316-2023
Product summary
- Event
- Event 91466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 bags
- Official record key
drug-enforcement:D-0316-2023
Official wording
Reason: Lack of sterility assurance
Code information: Beyond Use Date: December 24- 30, 2022
Distribution pattern: Dispensed to Patients Nationwide.
Derived failure modes
-
Sterility assurance
Lack of sterility