FDAFDA · Food and drugs·Recall number D-0508-2024
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
Published May 29, 2024 · Recall initiated: April 29, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hikma Injectables USA Inc
- Distributor
- CO, GA, PA, SD, WA
- Lot
- Lot #: 240310003D, Exp 6/4/2024
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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