Official Statement of Darnytsia Regarding the Falsification of the Medicinal Product Nalbuphin-Darnytsia

The company has received a notification regarding a suspected discrepancy in the packaging of Nalbuphin-Darnytsia, solution for injection 10 mg/ml, 2 ml ampoules No. 5, batch 1CG20924, purchased at a pharmacy in Dnipro. It was noted that this time the ampoules were made of clear glass, whereas previously the consumer received the product in light-protective glass, as required by regulatory documentation.

We officially confirm that this product is counterfeit and its origin is not related to our company’s manufacturing.

The State Service of Ukraine on Medicines and Drugs Control has already issued orders No. 442-001.1/002.0/17-25 and No. 445-001.1/002.0/17-25 dated July 9, 2025, prohibiting the sale, storage, and use of batches 1CG20924, 1CF30424, 1CF40424, 1CH20924 as counterfeit.

Currently, we are cooperating with regulatory authorities to establish the full distribution chain of this batch and to ensure the removal of the counterfeit product from pharmacies. We also appeal to all business entities to immediately check for the presence of batches 1CG20924, 1CF30424, 1CF40424, 1CH20924 and, if found, to withdraw them from circulation in accordance with the instructions of the State Service of Ukraine on Medicines.