Drug product
vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
D-0948-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,980 bags
- Official record key
drug-enforcement:D-0948-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-245576, Exp. 8/2/2023; 36-254436, 36-254442, Exp. 9/5/2023; 36-255131, Exp. 9/6/2023; 36-256045, Exp. 9/11/2023; 36-239523, Exp. 7/12/2023; 36-248987, Exp. 8/16/2023; 36-240797, Exp. 7/17/2023; 36-241979, Exp. 7/24/2023; 36-242705, Exp. 7/26/2023; 36-251733, 36-251738, Exp. 8/29/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility