Recall of a batch of SHMM1 with an expiration date of 8/2025 of the pharmaceutical product SIMULECT PS.SOL.INF 20.g/vial BT x 1 vial + 1amp solution after notification to NOVARTIS (HELLAS) SA about the presence of native glass particles in solvent ampoules with lot number M0797.

NOVARTIS (HELLAS) SA, as a local representative, must immediately contact the recipients of the product for instructions in the event of changing the solvent.

Alternatively, due to a declared shortage, in agreement with the company, only the solvent (batch M0797) can be replaced by an appropriate product licensed for sale in Greece to be used for product reconstitution.

Relevant documents are retained for at least five (5) years and are brought to the attention of EOF upon request.

See the EOF declaration here for details.