FDA Drug recall D-0963-2023
PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenu…
- FDA Drug
- Class II
- terminated
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenu… 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-0963-2023 |
| 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, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1.
Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Identifiers
| code_info | Lot: 36-240803, Exp. 7/17/2023; 36-241149, Exp. 7/19/2023; 36-241912, Exp. 7/23/2023; 36-243527, 36-243529, Exp. 7/30/2…Lot: 36-240803, Exp. 7/17/2023; 36-241149, Exp. 7/19/2023; 36-241912, Exp. 7/23/2023; 36-243527, 36-243529, Exp. 7/30/2023; 36-244889, 36-244890, 36-244891, Exp. 8/1/2023; 36-246709, 36-246710, 36-246711, 36-246712, Exp. 8/6/2023; 36-247014, Exp. 8/7/2023; 36-247611, 36-247614, 36-247616, 36-247629, 36-247631, 36-247640, Exp. 8/9/2023; 36-248282, 36-248283, 36-248285, Exp. 8/13/2023; 36-249217, 36-249219, 36-249221, 36-249223, Exp. 8/17/2023; 36-251389, 36-251390, 36-251391, Exp. 8/27/2023; 36-251512, Exp. 8/28/2023; 36-251971, 36-251973, Exp. 8/30/2023; 36-252468, Exp. 9/3/2023 |
|---|
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-0963-2023%22
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