Drug product
potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6060-1
D-0989-2023
Product summary
- Event
- Event 92707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7469 bags
- Official record key
drug-enforcement:D-0989-2023
Official wording
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Code information: Lot: 36-239332, Exp. 7/11/2023; 36-241113, Exp. 7/18/2023; 36-242467, 7/25/2023; 36-243530, 36-243659, Exp. 7/30/2023; 36-244888, 8/1/2023, 36-245657, 36-245658, Exp. 8/2/2023; 36-246835, Exp. 8/7/2023; 36-247595, Exp. 8/9/2023; 36-248736, Exp. 8/15/2023; 36-248984, 36-248985, Exp. 8/16/2023; 36-250054, 36-250055, 36-250056, 36-250057, 36-250058, Exp. 8/22/2023; 36-251046, 36-251047, 36-251048, 36-251049, Exp. 8/24/2023; 36-251975, Exp. 8/30/2023; 36-255877, 36-255878, 36-255879, Exp. 9/10/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility