Drug product
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper
D-0856-2021
Product summary
- Event
- Event 88698
- Status
- Terminated
- Classification
- Class II
- Quantity
- 963000 vials
- Official record key
drug-enforcement:D-0856-2021
Official wording
Reason: Defective container: Cracked vials leading to lack of sterility assurance
Code information: Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
lack of sterility