Drug 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
D-0508-2024
Product summary
- Event
- Event 94522
- Status
- Completed
- Classification
- Class I
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0508-2024
Official wording
Reason: Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Code information: Lot #: 240310003D, Exp 6/4/2024
Distribution pattern: CO, GA, PA, SD, WA
Derived failure modes
-
Labeling or packaging
mislabeled