Product Safety Recalls

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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

Mandated?Voluntary: Firm initiated
Recall NumberD-0508-2024
Event ID94522
DistributionCO, GA, PA, SD, WA
Recall ReasonLabeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Drug ClassificationClass I
Drug Code Info20240529
Recall Initiation Date20240429
Report Date20240529
Classification Date20240523
Address36 Stults Rd
Dayton, NJ 08810-1540
United States
Recalling FirmHikma Injectables USA Inc
Initial Notification Letter
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