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

FDA recall notice · announced May 29, 2024 · Hikma Injectables

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: CO, GA, PA, SD, WA
Lot/code information: Lot #: 240310003D, Exp 6/4/2024
Status: Completed
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.