Celon Pharma’s declaration on voluntary, temporary withdrawal of one batch of Salmex.

Celon Pharma S.A. voluntarily withdraws three batches of Salmex (500 µg + 50 µg)/ inhalation dose from the market.

Under a decision of the Chief Pharmaceutical Inspector no. 4/WS/2018, issued at the request of Celon Pharma S.A., the MAH, one batch of Salmex (500 µg + 50 µg), used in treatment of asthma and COPD has been withdrawn from the market.

NAME: SALMEX inhalation powder

DOSE: (500 µg + 50 µg)/inhalation dose

BATCH NUMBER: 223020018

EXPIRY DATE: 09.2019

The reason for the decision is the suspicion that qualitative requirements in the above-mentioned product batch have not been met in connection with internal explanatory proceedings regarding a result beyond the specification of another batch, manufactured on the same day. The preliminary results of this procedure confirm that it meets the relevant specification criteria. Therefore, the withdrawal of one product batch on the market is a preventive action taken in order to guarantee the highest quality of products delivered to patients.

However, the situation does not constitute a threat to the health and life of the patients using the drug. This batch of products is currently at an early stage of the distribution chain and to the best of the Company’s knowledge it has not reached the end users.

Withdrawal of the above-listed batches was carried out in accordance with a standard procedure provided for such situations in the pharmaceutical law. Celon Pharma S.A. is cooperating fully with the Chief Pharmaceutical Inspectorate.

Wholesale pharmacies and patients wishing to obtain more information on this matter can address their questions via email: [email protected].

More information can be obtained by contacting:

Magdalena Sobiecka – Grzenda
Head of Quality Assurance, Qualified Person, Celon Pharma S.A.:
phone: 502 057 284, email: [email protected]

Małgorzata Siewierska
Celon Pharma S.A. Press Office
[email protected]