Drugplain

levofloxacin 250 mg/1

levofloxacin · TABLET, FILM COATED · Redpharm Drug

10 Recalls on Record
Plain English

Levofloxacin is a fluoroquinolone antibiotic used to treat bacterial infections including respiratory tract infections, urinary tract infections, and skin infections. It works by killing bacteria that cause these infections and is taken by mouth as a film-coated tablet.

Key Facts

Brand Name
levofloxacin
Generic Name
levofloxacin
NDC Code (Product)
67296-2242
Manufacturer
Redpharm Drug
Strength
250 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA077652
Drug Class
Fluoroquinolone Antibacterial [EPC]
Marketing Start
01/10/2022

Recall History

10 Recalls on Record
Class II04/26/2023

Akorn, Inc.

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

OngoingVoluntary: 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
Class II03/27/2018

AuroMedics Pharma LLC

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

TerminatedVoluntary: Firm initiated
Class II10/13/2022

Akorn, Inc.

CGMP Deviations:

OngoingVoluntary: Firm initiated
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated
Class III02/07/2017

Actavis Inc

Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.

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
Class III08/01/2018

Baxter Healthcare Corporation

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

TerminatedVoluntary: Firm initiated
Class III08/01/2018

Baxter Healthcare Corporation

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

TerminatedVoluntary: Firm initiated
Class I01/12/2018

AuroMedics Pharma LLC

Presence of Particulate Matter; contains visible particulate matter identified as mold.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is levofloxacin used for?

Levofloxacin is a fluoroquinolone antibiotic used to treat bacterial infections including respiratory tract infections, urinary tract infections, and skin infections. It works by killing bacteria that cause these infections and is taken by mouth as a film-coated tablet.

Is levofloxacin a controlled substance?

levofloxacin is not classified as a controlled substance by the DEA.

What is the generic name for levofloxacin?

The generic name for levofloxacin is levofloxacin. There are 10 other brand versions of levofloxacin.

What is the NDC code for levofloxacin 250 mg/1?

The NDC (National Drug Code) for levofloxacin 250 mg/1 is 67296-2242, listed by Redpharm Drug.