Drug product
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
D-0658-2022
Product summary
- Event
- Event 89773
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 bag
- Official record key
drug-enforcement:D-0658-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 07292020@7 BUD: 8/12/2020
Distribution pattern: NC only
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility