Drug product
dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
D-0951-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,260 bags
- Official record key
drug-enforcement:D-0951-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-243946, 36-243947, 36-243948, 36-243949, Exp. 7/11/2023; 36-255120, Exp. 8/17/2023; 36-246829, 36-246831, 36-246832, Exp. 7/18/2023; 36-255961, Exp. 8/21/2023; 36-256896, Exp. 8/25/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility