Drug product
vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7060-1
D-0969-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,782 bags
- Official record key
drug-enforcement:D-0969-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-239519, 36-239518, Exp. 7/12/2023; 36-239992, Exp. 7/13/2023; 36-240844, Exp. 7/18/2023; 36-241983, Exp. 7/24/2023; 36-243151, Exp. 7/27/2023; 36-243950, Exp. 7/31/2023; 36-245538, 36-245544, Exp. 8/2/2023; 36-247881, Exp. 8/10/2023; 36-251053, Exp. 8/24/2023; 36-251707, 36-251714, Exp. 8/29/2023; 36-255496, 36-255497, 36-255498, 36-255499, Exp. 9/7/2023; 36-256320, 36-256322, Exp. 9/12/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility