Status
Terminated
Drug Enforcement D-1072-2023
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 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
- Product quantity
- 896 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-1072-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270540, Exp. 7/16/2023; 17-270663, Exp. 7/18/2023; 17-271059, Exp. 7/24/2023; 17-271249, Exp. 7/26/2023; 17-271593, Exp. 8/1/2023; 17-271742, Exp. 8/3/2023; 17-272064, Exp. 8/9/2023; 17-272106, Exp. 8/10/2023; 17-272279, Exp. 8/14/2023; 17-272530, Exp. 8/17/2023; 17-272603, Exp. 8/20/2023; 17-272776, Exp. 8/22/2023; 17-273075, Exp. 8/28/2023; 17-273344, Exp. 8/31/2023; 17-273409, Exp. 9/3/2023; 17-274221, 17-274222, Exp. 9/14/2023; 17-274414, Exp. 9/18/2023.
- More code info
- —