Digimerck 0.07 mg tablets show minor chemical deviation near expiry

A minor chemical deviation has been detected in Digimerck minor 0.07 mg tablets near the end of their shelf life. The issue involves a slight exceedance of the allowed limit for total degradation products. Authorities have confirmed that patient safety remains unaffected despite the finding.

The problem was uncovered through routine stability testing of the medication. In the final year before expiry, the total degradation products may rise to 1.7 percent, marginally above the 1.5 percent threshold. However, a toxicological review found no health risks for patients taking the tablets.

Distribution of Digimerck minor 0.07 mg tablets stopped in early 2023 after Merck halted supply in december 2022 due to ongoing production difficulties. The last authorised distributor, Rottendorf Pharma GmbH, was officially delisted by the German Federal Institute for Drugs and Medical Devices (BfArM) in december 2024, with no replacements recorded. Any remaining stock, expiring in october 2026, may still be in circulation.

Merck, in coordination with the Hessian State Office for Health and Care (HLfGP) and BfArM, has stated that the medication's efficacy and safety remain unchanged. The benefit-risk assessment stays positive, and no adverse reactions linked to this issue have been reported. Patients using any leftover tablets are advised to report potential side effects through BfArM's adverse event portal.

The product will remain under observation until the expiry of any remaining batches in october 2026. Authorities have emphasised that the slight exceedance does not compromise patient safety. Monitoring will continue, and healthcare providers are encouraged to stay vigilant for any unexpected effects.