D-0508-2024Class I

Hikma Injectables USA Inc

Recalling firm

Product type

Drug

Status

Completed

Report date

2024-05-29

Distribution

CO, GA, PA, SD, WA

Firm state

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Product description

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

Code / lot info

Lot #: 240310003D, Exp 6/4/2024

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See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.