FDA Drug recall D-0965-2023
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043,…
- FDA Drug
- Class II
- terminated
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043,… by Central Admixture Pharmacy Services, citing lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0965-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-07-14 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Central Admixture Pharmacy Services |
| Distribution | US |
Product
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Identifiers
| code_info | Lot: 36-239063, 36-239064, 36-239065, 36-239066, 36-239067, 36-23906, 736-239068, 36-239069, 36-239204, Exp. 7/10/2023;…Lot: 36-239063, 36-239064, 36-239065, 36-239066, 36-239067, 36-23906, 736-239068, 36-239069, 36-239204, Exp. 7/10/2023; 36-239196, 36-239197, 36-239198, 36-239199, 36-239200, 36-239201, 36-239202, 36-239203, 36-239205, 36-239206, Exp. 7/11/2023; 36-239483, 36-239487, 36-239488, 36-239489, 36-239490, 36-239639, 36-239640, 36-239641, Exp. 7/12/2023; 36-239788, 36-239789,36-239790, 36-239793, 36-239797, 36-239798, Exp. 7/13/2023; 36-240139, 36-240140, 36-240141, 36-240142, 36-240143, Exp. 7/16/2023; 36-240319, 36-240320, 36-240321 ,36-240322, 36-240812, Exp. 7/17/2023; 36-241074, 36-241075, 36-241076, 36-241077, Exp. 7/18/2023; 36-241136, Exp. 7/19/2023; 36-241357, 36-241358, 36-241359, 36-241372, 36-241373, Exp. 7/20/2023; 36-241715, 36-241718, 36-241719, 36-241720, 36-241721, 36-241723, 36-241850, Exp. 7/21/2023; 36-241918, 36-241919, 36-241920, 36-242184, Exp. 7/23/2023; 36-241993, 36-241994, 36-241995, 36-241997, Exp. 7/24/2023; 36-242402, 36-242403, 36-242404, 36-242405, 36-242406, 3 |
|---|
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-0965-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.