Drug product
Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
D-0134-2019
Product summary
- Event
- Event 81413
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 bags
- Official record key
drug-enforcement:D-0134-2019
Official wording
Reason: Lack of assurance of sterility
Code information: Lot# 138-20182308@88, Exp 11/06/2018
Distribution pattern: U.S.A. nationwide.
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility