Class II

Drug Recall: phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

Hikma Injectables USA Inc · December 19, 2024

Reason for Recall

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0174-2025

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Hikma Injectables USA Inc Drug Recall: phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25 | SafeCheck