Drugplain

0.9% SODIUM CHLORIDE 900 mg/100mL

0.9% SODIUM CHLORIDE · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst

10 Recalls on Record
Plain English

0.9% SODIUM CHLORIDE is a injection, solution containing 0.9% sodium chloride at 900 mg/100mL, taken intravenous. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.

Key Facts

Brand Name
0.9% SODIUM CHLORIDE
Generic Name
0.9% SODIUM CHLORIDE
NDC Code (Product)
51662-1518
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Strength
900 mg/100mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA016366
Marketing Start
04/07/2020

Recall History

10 Recalls on Record
Class II05/05/2016

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

TerminatedVoluntary: Firm initiated
Class II07/14/2017

SCA Pharmaceuticals

Lack of Assurance of Sterility; product has the potential to leak.

TerminatedVoluntary: Firm initiated
Class II07/20/2023

SCA Pharmaceuticals

cGMP deviations: due to shipment of rejected units.

TerminatedVoluntary: Firm initiated
Class II07/25/2022

SterRx, LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II11/09/2023

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II07/14/2017

Cantrell Drug Company

Lack of Sterility Assurance.

TerminatedVoluntary: Firm initiated
Class II07/17/2015

Pharmedium Services, LLC

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

TerminatedVoluntary: Firm initiated
Class I02/03/2017

SCA Pharmaceuticals

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

TerminatedVoluntary: Firm initiated
Class II06/17/2016

Teva North America

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II07/07/2023

SterRx, LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is 0.9% SODIUM CHLORIDE used for?

0.9% SODIUM CHLORIDE contains 0.9% SODIUM CHLORIDE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is 0.9% SODIUM CHLORIDE a controlled substance?

0.9% SODIUM CHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for 0.9% SODIUM CHLORIDE?

The generic name for 0.9% SODIUM CHLORIDE is 0.9% SODIUM CHLORIDE. There are 1 other brand versions of 0.9% SODIUM CHLORIDE.

What is the NDC code for 0.9% SODIUM CHLORIDE 900 mg/100mL?

The NDC (National Drug Code) for 0.9% SODIUM CHLORIDE 900 mg/100mL is 51662-1518, listed by HF Acquisition Co LLC, DBA HealthFirst.

Product NDC

51662-1518

Package NDC

51662-1518-1

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)