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Eberth Antibiotics - Outdated Package Inserts Create Patient Safety Risk

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Summary

Dr. Friedrich Eberth Arzneimittel GmbH issued a Direct Healthcare Professional Communication (DHPC) via BfArM alerting that certain batches of nine antibiotic and antifungal products have outdated package inserts, creating a potential patient safety risk. Affected products include multiple strengths of cefazolin, cefotaxime, ceftazidime, ceftriaxone, levofloxacin, moxifloxacin, and voriconazole. Healthcare professionals are advised to discard outdated package inserts and refer to the current package inserts provided with the communication.

What changed

Dr. Friedrich Eberth Arzneimittel GmbH issued a Direct Healthcare Professional Communication (DHPC) via BfArM regarding outdated package inserts for nine specific antibiotic and antifungal products that may pose a patient safety risk. The affected products include Cefazolin Dr. Eberth 2 g, Cefotaxim Eberth 0.5 g, Ceftazidim Dr. Eberth 500 mg and 2 g, Ceftriaxon Eberth 1 g and 2 g, Levofloxacin Dr. Eberth 5 mg/ml, Moxifloxacin Eberth 400 mg/250 ml, and Voriconazol Eberth 200 mg.\n\nHealthcare providers should identify whether they hold stock of these affected batches, discard any outdated package inserts already received with the products, and refer to the current package inserts provided in the DHPC. This is a pharmacovigilance safety communication rather than a product recall, so affected products may remain in use with updated documentation.

What to do next

  1. Identify affected Eberth product batches in stock
  2. Discard outdated package inserts for listed products
  3. Refer to current package inserts provided in the DHPC

Archived snapshot

Apr 12, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Direct Healthcare Professional Communication (DHPC) on various medicinal products from Dr. Friedrich Eberth Arzneimittel GmbH: risk due to outdated package inserts

2026.03.30

Active substance: cefazolin, cefotaxime, ceftazidime, ceftriaxone, levofloxacin, moxifloxacin, voriconazol

The company Dr. Friedrich Eberth Arzneimittel GmbH informs about a potential risk to patient safety due to outdated package inserts for certain batches of the following medicinal products:

  • Cefazolin Dr. Eberth 2 g Pulver zur Herstellung einer Injektions-/Infusionslösung
  • Cefotaxim Eberth 0,5 g Pulver zur Herstellung einer Injektionslösung
  • Ceftazidim Dr. Eberth 500 mg Pulver zur Herstellung einer Injektionslösung
  • Ceftazidim Dr. Eberth 2 g Pulver zur Herstellung einer Injektions- bzw. Infusionslösung
  • Ceftriaxon Eberth 1 g Pulver zur Herstellung einer Injektionslösung
  • Ceftriaxon Eberth 2 g Pulver zur Herstellung einer Infusionslösung
  • Levofloxacin Dr. Eberth 5 mg / ml Infusionslösung
  • Moxifloxacin Eberth 400 mg /250 ml Infusionslösung
  • Voriconazol Eberth 200 mg Pulver zur Herstellung einer Infusionslösung The company asks to discard the package inserts for the affected packages that have already been received and refer to the current package inserts as shown below.

Download DHPC/Information letter, DownloadVeroeffentlichtAmEN

2026.03.30

PDF, 2MB, File does not meet accessibility standards

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Last updated

Classification

Agency
BfArM
Published
March 30th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Pharmaceutical companies Patients
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Pharmaceutical distribution Drug labeling Patient safety communication
Geographic scope
Germany DE

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Regulatory Affairs
Compliance frameworks
GxP
Topics
Public Health Medical Devices

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