FDA Drug recall D-0508-2024
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Ro…
- FDA Drug
- Class I
- completed
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class I recall of Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Ro… by Hikma Injectables Usa, citing labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0508-2024 |
| Classification | Class I |
| Status | completed |
| Initiated | 2024-04-29 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Injectables Usa |
| Distribution | CO, GA, PA, SD, WA |
Product
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Reason
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Identifiers
| code_info | Lot #: 240310003D, Exp 6/4/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0508-2024%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.