Drug product
EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
D-1129-2023
Product summary
- Event
- Event 92898
- Status
- Terminated
- Classification
- Class II
- Quantity
- 340 bags
- Official record key
drug-enforcement:D-1129-2023
Official wording
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Code information: Lot# 36-260049, Exp 10/3/2023. ;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility