Recall
FDAHealthDecember 19, 2024

Hikma Injectables USA Inc — 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

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
December 19, 2024

Nationwide in the USA

What's affected?

Product
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
Lot code
243120003D

Additional details

Lot number: 243120003D, Use by Date: 03/11/2025

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated

View original FDA notice →

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