Recall D-0508-2024
Description: 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
Recall D-0508-2024 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0508-2024 |
Event ID | 94522 |
Distribution | CO, GA, PA, SD, WA |
Recall Reason | Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. |
Drug Classification | Class I |
Drug Code Info | 20240529 |
Recall Initiation Date | 20240429 |
Report Date | 20240529 |
Classification Date | 20240523 |
Address | 36 Stults Rd Dayton, NJ 08810-1540 United States |
Recalling Firm | Hikma Injectables USA Inc |
Initial Notification | Letter |
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