Status
Terminated
Drug Enforcement D-0969-2023
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 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7060-1
- Product quantity
- 6,782 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-0969-2023
- Event ID
- 92707
- Recall initiation date
- July 14, 2023
- Center classification date
- August 1, 2023
- Code info
- Lot: 36-239519, 36-239518, Exp. 7/12/2023; 36-239992, Exp. 7/13/2023; 36-240844, Exp. 7/18/2023; 36-241983, Exp. 7/24/2023; 36-243151, Exp. 7/27/2023; 36-243950, Exp. 7/31/2023; 36-245538, 36-245544, Exp. 8/2/2023; 36-247881, Exp. 8/10/2023; 36-251053, Exp. 8/24/2023; 36-251707, 36-251714, Exp. 8/29/2023; 36-255496, 36-255497, 36-255498, 36-255499, Exp. 9/7/2023; 36-256320, 36-256322, Exp. 9/12/2023.
- More code info
- —