Drug product
Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
D-0132-2019
Product summary
- Event
- Event 81413
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 syringes
- Official record key
drug-enforcement:D-0132-2019
Official wording
Reason: Lack of assurance of sterility
Code information: Lot # 8/8/18 0200 15-21070S, Exp 11/06/2018
Distribution pattern: U.S.A. nationwide.
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility