Status
Terminated
Drug Enforcement D-1050-2023
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
- fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
- Product quantity
- 848 bags
- 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-1050-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270533, Exp. 7/16/2023; 17-270580, 17-270581, Exp. 7/17/2023; 17-270654, Exp. 7/18/2023; 17-271044, Exp. 7/24/2023; 17-271243, Exp. 7/26/2023; 17-271439, Exp. 7/30/2023; 17-271562, Exp. 8/1/2023.
- More code info
- —