Status
Terminated
Drug Enforcement D-1055-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Classification
Class II
Report Date
August 9, 2023
Termination Date
March 21, 2025
Product Information
- Product description
- HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
- Product quantity
- 2,389 syringes
- Reason for recall
- Lack of assurance of sterility: Lack of validation data for sanitization cycles
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Central Admixture Pharmacy Services Inc
- Address
-
7935 Dunbrook Rd Ste C, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1055-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270530, Exp. 7/16/2023; 17-270871, Exp. 7/20/2023; 17-271153, Exp. 7/25/2023; 17-271275, Exp. 7/26/2023; 17-271417, Exp. 7/30/2023; 17-271671, Exp. 8/2/2023; 17-271883, Exp. 8/7/2023; 17-271992, Exp. 8/8/2023; 17-272050, Exp. 8/9/2023; 17-272103, Exp. 8/10/2023; 17-272368, 17-272369, Exp. 8/15/2023; 17-272451, Exp. 8/16/2023; 17-273172, Exp. 8/29/2023; 17-273782, Exp. 9/7/2023.
- More code info
- —