Status
Terminated
Drug Enforcement D-0989-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Classification
Class II
Report Date
August 9, 2023
Termination Date
March 28, 2025
Product Information
- Product description
- 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
- Product quantity
- 7469 bags
- Reason for recall
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Address
-
2200 S 43rd Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0989-2023
- Event ID
- 92707
- Recall initiation date
- July 14, 2023
- Center classification date
- August 1, 2023
- Code info
- 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.
- More code info
- —