Soltopin ointment recalled in Poland due to quality concerns

The Chief Pharmaceutical Inspectorate (GIF) has issued an immediate recall for a specific batch of Soltopin ointment in Poland. The recall affects the 15 g tubes of the 20 mg/g mupirocin ointment, specifically batch number S082414.1, which has an expiration date of August 2026.

Long-term stability studies revealed that the active substance concentration fell below the required limit, potentially compromising the medication's efficacy. Additionally, the batch exceeded permissible levels of impurities, including Mupirocin I and other unidentified substances, which poses a safety risk to patients. The issue was traced to a specific batch of an auxiliary ingredient used during production.

The responsible entity for the product is the German company INFECTOPHARM Arzneimittel und Consilium GmbH. Patients are advised to check their home medicine cabinets for the affected batch number.