Drug product
vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/mL), IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6071-1
D-0971-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1927 bags
- Official record key
drug-enforcement:D-0971-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-239990, Exp. 7/13/2023; 36-240839, Exp. 7/18/2023; 36-242706, Exp. 7/26/2023; 36-243952, Exp. 7/31/2023; 36-253889, Exp. 8/31/2023; 36-255691, Exp. 9/7/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility