Tue Mar 10 11:10:00 UTC 2026: Headline: Zentiva Recalls Ibuflam 600 Tablets Due to Metallic Foreign Body

The Story:
Zentiva is recalling a specific batch (5R02514) of Ibuflam 600 tablets (50-tablet packs) after a metallic foreign body was discovered in one tablet. The recall is limited to pharmacies and wholesalers, who are instructed to check their inventories and return the affected packages. While there is no patient-level recall, patients can return potentially affected packs to pharmacies for a replacement.

Key Points:
* Batch 5R02514 of Ibuflam 600 (50 tablets) is being recalled.
* The recall is due to the discovery of a metallic foreign body in one tablet.
* The recall is limited to pharmacies and wholesalers, not patients.
* Patients can return affected packs to pharmacies for a replacement through a standard quality complaint process.
* Pharmacies will handle returns through wholesalers.
* A replacement is possible via the pharmacy if a quality defect is suspected.
* Pharmacies must report the quality complaint to Zentiva and provide a replacement after consultation with and on behalf of Zentiva.
* A special Pharmaceutical Central Number (06461067) will be printed in the field “Drug Identification Code”.
* In the “Factor” field, the number of replacement packs will be printed and in the “Tax” field a “0” will be printed – as well as in the “Additional Payment” field.

Key Takeaways:
* A localized quality control issue has been identified in a specific batch of Ibuflam 600.
* Zentiva is implementing a standard recall and replacement process to address the issue.
* Patients are not directly impacted by the recall but can seek replacements through pharmacies.
* The recall process involves close coordination between Zentiva and pharmacies.
* The process adheres to the regulations of the German Medicines Act (AMG) and the German Medicines and Active Substance Manufacturing Ordinance (AmWHV).

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