Drug product
Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
D-0133-2019
Product summary
- Event
- Event 81413
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360 bags
- Official record key
drug-enforcement:D-0133-2019
Official wording
Reason: Lack of assurance of sterility
Code information: Lot # 8/27/18 0215 22110P, Exp 12/10/2018
Distribution pattern: U.S.A. nationwide.
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility