Armenia’s Health and Labor Inspection Body has ordered THEOPHARMA IMPORT LLC to immediately suspend the distribution and recall a specific batch of Gensulin R 100 IU/mL solution for injection.
The recall applies to batch 50C2607A of the product, supplied in 10 mL glass vials and manufactured by Bioton S.A.
According to the Inspection Body, the decision was based on an expert assessment conducted by the Center for Expertise of Medicines and Medical Technologies, which identified a Class II quality defect in the affected batch.
During a visual inspection, specialists detected a small particle measuring approximately 0.1–1 mm attached to the inner surface of the glass vial. As a result, the entire 50C2607A batch has been ordered to be withdrawn from circulation and recalled.
The Health and Labor Inspection Body urges patients and healthcare providers to check the batch number of any Gensulin R 100 IU/mL vials they possess. If the batch number is 50C2607A, the product should not be used, and consumers should follow the guidance of their healthcare provider or pharmacist regarding its replacement.
