Status
Terminated
Drug Enforcement D-0967-2023
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
- vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6176-1
- Product quantity
- 6,772 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-0967-2023
- Event ID
- 92707
- Recall initiation date
- July 14, 2023
- Center classification date
- August 1, 2023
- Code info
- Lot: 36-238968, 36-238985, 36-238992, 36-238998, Exp. 7/10/2023; 36-240784, 36-240785, 36-240786, 36-240787, Exp. 7/17/2023; 36-240840, 36-240842, Exp. 7/18/2023; 36-243157, Exp. 7/27/2023; 36-243953, Exp. 7/31/2023; 36-251050, 36-251051, 36-251059, Exp. 8/24/2023; 36-252196, 36-252197, 36-252200, Exp. 8/31/2023; 36-254418, Exp. 9/5/2023; 36-256916, Exp. 9/13/2023.
- More code info
- —