“For the presence of native glass particles in the ampoules” says the EOF
The EOF is proceeding with a batch recall of the pharmaceutical product SIMULECT PS.SOL.INF 20, g/vial BT x 1vial + 1amp solv as, according to Novartis, glass particles were detected.
The EOF announcement:
“On the recall of batch SHMM1 with expiry date 8/2025 of the pharmaceutical product SIMULECT PS.SOL.INF 20,g/vial BT x 1vial + 1amp solv, following notification of the company NOVARTIS (HELLAS) SA for the presence of native glass particles in its ampoules solvent with lot number M0797, EOF proceeded.
The company NOVARTIS (HELLAS) SA, as a Local Representative, must immediately contact the recipients of the product in order to be given instructions in case of replacement of the solvent.
Alternatively, due to the declared shortage, in consultation with the company, only the solvent (batch M0797) can be replaced, with a corresponding product that has a marketing license in Greece, in order to be used for the reconstitution of the product.
The relevant documents are kept for a period of at least five (5) years and are brought to the attention of the EOF, if requested”.
Source: Skai
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