Status
Terminated
Drug Enforcement D-0953-2023
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
- 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
- Product quantity
- 3,699 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-0953-2023
- Event ID
- 92707
- Recall initiation date
- July 14, 2023
- Center classification date
- August 1, 2023
- Code info
- 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.
- More code info
- —