Digimerck Tablets Quality Defect: Degradation Products May Exceed Limit
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
- Monitor patients using remaining stock of Digimerck 0.07 mg tablets
- 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
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