FDA Drug recall D-1059-2023
fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935…
- FDA Drug
- Class II
- terminated
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935… 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-1059-2023 |
| 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 in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Identifiers
| code_info | Lot: 17-270499, 17-270500, 17-270503, 17-270511, 17-270518, 17-270544, Exp. 7/16/2023; 17-270778, 17-270779, Exp. 7/19/…Lot: 17-270499, 17-270500, 17-270503, 17-270511, 17-270518, 17-270544, Exp. 7/16/2023; 17-270778, 17-270779, Exp. 7/19/2023; 17-270957, 17-270958, 17-270959, 17-270965, 17-270972, 17-270982, 17-270984, 17-270985, Exp. 7/23/2023; 17-271043, Exp. 7/24/2023; 17-271232, 17-271240, 17-271266, Exp. 7/26/2023; 17-271326, 17-271327, 17-271328, 17-271329, 17-271341, 17-271342, Exp. 7/27/2023; 17-271399, 17-271400, 17-271401, Exp. 7/30/2023; 17-271481, 17-271482, 17-271483, 17-271488, 17-271489, 17-271491, 17-271510, Exp. 7/31/2023; 17-271590, 17-271661, Exp. 8/1/2023; 17-271655, 17-271656, 17-271668, 17-271675, 17-271677, Exp. 8/2/2023; 17-271759, Exp. 8/3/2023; 17-271825, Exp. 8/6/2023; 17-271880, 17-271881, 17-271885, Exp. 8/7/2023; 17-271939, 17-271941, 17-271942, 17-271952, 17-271961, Exp. 8/8/2023; 17-272017, 17-272018, 17-272066, Exp. 8/9/2023; 17-272107, Exp. 8/10/2023; 17-272211, Exp. 8/13/2023; 17-272354, 17-272356, 17-272365, 17-272376, 17-272380, Exp. 8/15/2023; 17-272448, 17-272450 |
|---|
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-1059-2023%22
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