Phenylephrine in 0 recalled over sterility concerns

Recall date

December 19, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Hikma Injectables USA Inc recalls phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults R…

Recall number

D-0174-2025

FDA classification

Class II

Brand / firm

Hikma Injectables USA Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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