Drug product
vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1
D-0950-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4824 bags
- Official record key
drug-enforcement:D-0950-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-245562, Exp. 8/2/2023; 36-254425, Exp. 9/5/2023; 36-255129, Exp. 9/6/2023; 36-238965, Exp. 7/10/2023; 36-256041, Exp. 9/11/2023; 36-241129, 36-241130, Exp. 7/19/2023; 36-241438, Exp. 7/20/2023; 36-242703, Exp. 7/26/2023; 36-243163, 36-243164, Exp. 7/27/2023; 36-251724, 36-251727, Exp. 8/29/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility