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Priority review Notice Amended Final

Digimerck Tablets Quality Defect: Degradation Products May Exceed Limit

Favicon for www.bfarm.de BfArM Drug Safety Communications
Published January 28th, 2026
Detected March 13th, 2026
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Summary

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a Direct Healthcare Professional Communication regarding Digimerck 0.07 mg tablets. A quality defect has been identified where degradation products may slightly exceed the specification limit by the end of the product's shelf life. Distribution was discontinued in 2022.

What changed

Merck Healthcare Germany GmbH has alerted healthcare professionals to a quality defect concerning Digimerck 0.07 mg tablets. The sum of degradation products may slightly exceed the specification limit towards the end of the product's shelf life. Although distribution of this drug was halted in 2022, the communication emphasizes the need to monitor patients who may still be using remaining stock and to report any adverse effects.

Healthcare providers should be aware of this potential quality issue and proactively monitor patients using any residual Digimerck 0.07 mg tablets. Any observed side effects should be reported to the relevant authorities. While no immediate compliance actions are required due to the discontinuation of distribution, vigilance regarding patient safety and pharmacovigilance reporting remains critical.

What to do next

  1. Monitor patients using remaining stock of Digimerck 0.07 mg tablets
  2. Report any observed side effects to the relevant authorities

Source document (simplified)

Direct Healthcare Professional Communication (DHPC) on Digimerck 0,07 mg Tablets: The sum of the degradation products may slightly exceed the specification limit at the end of shelf life

2026.01.28

Active substance: digitoxine

The company Merck Healthcare Germany GmbH informs about a quality defect in Digimerck 0.07 mg tablets. The sum of the degradation products may slightly exceed the specification limit in the last year of shelf life. Distribution of the drug was discontinued in 2022, but it is recommended that patients who may be using remaining stocks of the drug be monitored and any side effects reported.

Download DHPC/Information letter, DownloadVeroeffentlichtAmEN

2026.01.28

PDF, 136KB, File does not meet accessibility standards

Classification

Agency
Various
Published
January 28th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Drug manufacturers Healthcare providers Patients
Geographic scope
Germany

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Product Safety Healthcare

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