Drug product
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00409-2634-50
D-0296-2023
Product summary
- Event
- Event 91466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37 bags
- Official record key
drug-enforcement:D-0296-2023
Official wording
Reason: Lack of sterility assurance
Code information: Beyond Use Date: December 24-31, 2022
Distribution pattern: Dispensed to Patients Nationwide.
Derived failure modes
-
Sterility assurance
Lack of sterility