FDA Drug recall D-1069-2023
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…
- FDA Drug
- Class II
- terminated
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of 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… by Central Admixture Pharmacy Services, citing lack of assurance of sterility: Lack of validation data for sanitization cycles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1069-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-07-17 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Central Admixture Pharmacy Services |
| Distribution | US |
Product
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
Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Identifiers
| code_info | Lot: 17-271814, Exp. 8/6/2023; 17-271960, Exp. 8/8/2023; 17-272252, Exp. 8/13/2023; 17-272272, Exp. 8/14/2023; 17-27245…Lot: 17-271814, Exp. 8/6/2023; 17-271960, Exp. 8/8/2023; 17-272252, Exp. 8/13/2023; 17-272272, Exp. 8/14/2023; 17-272454, Exp. 8/16/2023; 17-272640, Exp. 8/20/2023; 17-272716, Exp. 8/21/2023. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1069-2023%22
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