Drug product
vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1
D-0968-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,914 bags
- Official record key
drug-enforcement:D-0968-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-239516, 36-239517, Exp. 7/12/2023; 36-239989, Exp. 7/13/2023; 36-240798, Exp. 7/17/2023; 36-241133, Exp. 7/19/2023; 36-241981, Exp. 7/24/2023; 36-242717, Exp. 7/26/2023; 36-245577, Exp. 8/2/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility