Status
Terminated
Drug Enforcement D-1079-2023
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 in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1
- Product quantity
- 6,770 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-1079-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270539, Exp. 7/16/2023; 17-270981, Exp. 7/23/2023; 17-271167, Exp. 7/25/2023; 17-271337, Exp. 7/27/2023; 17-271827, Exp. 8/6/2023; 17-272214, Exp. 8/13/2023; 17-272536, 17-272555, Exp. 8/17/2023; 17-273424, 17-273432, Exp. 9/3/2023; 17-273476, Exp. 9/4/2023; 17-273882, Exp. 9/10/2023; 17-274044, Exp. 9/12/2023.
- More code info
- —