Status
Terminated
Drug Enforcement D-1043-2023
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, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
- Product quantity
- 5,124 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-1043-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270664, Exp. 7/18/2023; 17-270886, Exp. 7/20/2023; 17-270976, 17-270989, Exp. 7/23/2023; 17-271335, Exp. 7/27/2023; 17-271572, Exp. 8/1/2023; 17-271747, Exp. 8/3/2023; 17-271808, Exp. 8/6/2023; 17-272023, Exp. 8/9/2023; 17-272203, Exp. 8/13/2023; 17-272718, Exp. 8/21/2023; 17-272797, Exp. 8/22/2023; 17-273157, Exp. 8/29/2023; 17-273507, Exp. 9/4/2023; 17-273766, Exp. 9/7/2023; 17-273862, Exp. 9/10/2023; 17-274052, Exp. 9/12/2023; 17-274208, Exp. 9/14/2023.
- More code info
- —