Status
Terminated
Drug Enforcement D-1054-2023
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, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
- Product quantity
- 2,082 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-1054-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-271133, 17-271155, Exp. 7/25/2023; 17-271568, 17-271569, Exp. 8/1/2023; 17-271741, 17-271762, Exp. 8/3/2023; 17-272051, Exp. 8/9/2023; 17-272227, Exp. 8/13/2023; 17-272343, Exp. 8/15/2023; 17-272799, Exp. 8/22/2023; 17-273173, Exp. 8/29/2023; 17-273495, Exp. 9/4/2023.
- More code info
- —