FDA Recall D-0508-2024
Hikma Injectables USA Inc · Dayton, NJ
Class I — life-threatening Completed 745 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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 for recall
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Recall record
- Recall number
D-0508-2024- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- CO, GA, PA, SD, WA
- Recall initiated
- 2024-04-29
- Classified by FDA Center
- 2024-05-23
- FDA published
- 2024-05-29
- Recalling firm
- Hikma Injectables USA Inc
- Firm location
- Dayton, NJ