Drugplain

ephedrine sulfate 5 mg/mL

ephedrine sulfate · INJECTION · Fresenius Kabi USA, LLC

10 Recalls on Record
Plain English

ephedrine sulfate is a injection containing ephedrine sulfate at 5 mg/mL, taken intravenous. Manufactured by Fresenius Kabi USA, LLC.

Key Facts

Brand Name
ephedrine sulfate
Generic Name
ephedrine sulfate
NDC Code (Product)
65219-548
Manufacturer
Fresenius Kabi USA, LLC
Strength
5 mg/mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA218271
Marketing Start
07/07/2025

Recall History

10 Recalls on Record
Class II12/17/2020

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

TerminatedVoluntary: Firm initiated
Class II06/12/2018

Avella of Deer Valley, Inc. Store 38

Lack of Assurance of Sterility: Potential leakage of bags.

TerminatedVoluntary: Firm initiated
Class II07/14/2017

Cantrell Drug Company

Lack of Sterility Assurance.

TerminatedVoluntary: Firm initiated
Class II08/19/2015

Pharmakon Pharmaceuticals

Stability data does not support expiry.

TerminatedVoluntary: Firm initiated
Class II06/12/2018

Avella of Deer Valley, Inc. Store 38

Lack of Assurance of Sterility: Potential leakage of bags.

TerminatedVoluntary: Firm initiated
Class II12/27/2017

Pharmedium Services, LLC

Lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II03/16/2020

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II04/20/2016

Pharmakon Pharmaceuticals, Inc.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II03/16/2020

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated

Frequently Asked Questions

What is ephedrine sulfate used for?

ephedrine sulfate contains ephedrine sulfate. It is a injection taken intravenous. Consult your doctor for specific uses.

Is ephedrine sulfate a controlled substance?

ephedrine sulfate is not classified as a controlled substance by the DEA.

What is the generic name for ephedrine sulfate?

The generic name for ephedrine sulfate is ephedrine sulfate. There are 11 other brand versions of ephedrine sulfate.

What is the NDC code for ephedrine sulfate 5 mg/mL?

The NDC (National Drug Code) for ephedrine sulfate 5 mg/mL is 65219-548, listed by Fresenius Kabi USA, LLC.