Status
Terminated
Drug Enforcement D-0016-2024
Lack of assurance of sterility:
Classification
Class II
Report Date
October 11, 2023
Termination Date
March 19, 2025
Product Information
- Product description
- fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1
- Product quantity
- 60 250 mL bags
- Reason for recall
- Lack of assurance of sterility:
- 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-0016-2024
- Event ID
- 93103
- Recall initiation date
- September 21, 2023
- Center classification date
- October 4, 2023
- Code info
- Lot: 17-275929, Exp. 10/12/2023,
- More code info
- —