Levofloxacin shortage — CA supply status & alternatives

Levofloxacin

—

In supply · Australia

Apo-Levofloxacin

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇺🇸 US🇧🇪 BE

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

In supply

no shortage substitution needed

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Brand names
Active ingredient (INN)	Levofloxacin

Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper

Controlled substance	No

Marketing-authorisation holders	ACCORD-UK LIMITED, SANDOZ LIMITED, ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPA, FRESENIUS KABI LIMITED +5 more

Registrations on file	15

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

Other markets

🇺🇸 US

US$0.28

Acquisition

🇬🇧 GB

£4.11

Drug Tariff

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

24 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Low concentration risk✓ 3 WHO-prequalified

Cipla LTDZydus Lifesciences LTDMatrix Pharmacorp Private LTDZhejiang Langhua Pharmaceutical Co LtdShaoxing Jingxin Pharmaceutical Co LtdZhejiang East-Asia Pharmaceutical Co Ltd+18 more

Manufacturing countries: India, China, Israel, Brazil, Mexico, Spain · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

Levofloxacin Ophthalmic Solution

Akorn, Inc. · Apr 2023

Class IIdetails ↗

🇺🇸

Levofloxacin Oral Solution

Akorn, Inc. · Apr 2023

Class IIdetails ↗

🇺🇸

Levofloxacin Injection

Akorn, Inc. · Apr 2023

Class IIdetails ↗

🇺🇸

Levofloxacin Tablets

MACLEODS PHARMA USA, INC · Jan 2023

Class IIIdetails ↗

🇺🇸

Levofloxacin Ophthalmic Solution

Akorn, Inc. · Oct 2022

Class IIdetails ↗

🇺🇸

LEVOFLOXACIN

Mckesson Medical-Surgical Inc. Corporate Office · Apr 2022

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders15 registrations · 9 MA holders

Product	Strength	Form	Market	MA holder	Status
LEVOFLOXACIN 5MG/ML EYE DROPS SOLUTION	5MG	solution	🇬🇧 GB	ACCORD-UK LIMITED	Active
LEVOFLOXACIN 250MG FILM-COATED TABLETS	250MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
LEVOFLOXACIN 500MG FILM-COATED TABLETS	500MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
LEVOFLOXACIN 250 MG FILM-COATED TABLETS	250 MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
LEVOFLOXACIN 500 MG FILM-COATED TABLETS	500 MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
LEVOFLOXACIN 5MG/ML SOLUTION FOR INFUSION	5MG	solution	🇬🇧 GB	ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPA	Active
Levofloxacin Kabi	5 MG	solution	🇬🇧 GB	FRESENIUS KABI LIMITED	Active
LEVOFLOXACIN 250 MG FILM - COATED TABLETS	250 MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
LEVOFLOXACIN 500 MG FILM - COATED TABLETS	500 MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
LEVOFLOXACIN 5 MG/ML SOLUTION FOR INFUSION	5 MG	solution	🇬🇧 GB	NORIDEM ENTERPRISES LIMITED	Active
Levofloxacin Ibigen	5 MG	solution	🇬🇧 GB	IBIGEN SRL	Active
LEVOFLOXACIN 5MG/ML EYE DROPS, SOLUTION	5MG	solution	🇬🇧 GB	ASPIRE PHARMA LIMITED	Active
LEVOFLOXACIN 5 MG/ML EYE DROPS, SOLUTION IN SINGLE DOSE CONTAINER	5 MG	solution	🇬🇧 GB	ASPIRE PHARMA LIMITED	Active
Levofloxacin	250mg/50mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Levofloxacin	500mg/100mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.