Drug product
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
D-0953-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,699 bags
- Official record key
drug-enforcement:D-0953-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-244893, 36-244894, 36-244895, Exp. 7/12/2023; 36-246428, 36-246429, 36-246647, 36-246648, Exp. 7/14/2023; 36-254364, 36-254365, 36-254366, 36-254367, 36-254368, Exp. 8/15/2023; 36-246824, 36-246825, 36-246828, Exp. 7/18/2023; 36-256157, Exp. 8/21/2023; 36-256890, Exp. 8/25/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility