A decision has been issued by the National Medicines Agency (NDA) to support the voluntary recall of the company producing the drug.
The EOF announced today Monday (23.03.2026) the recall of batch 1204161C with an expiry date of 28/4/2026 for the drug CUROSURF SUS.TR.INS 120mg/1.5ml.
This voluntary recall follows a deviation in the results of Grade A environmental monitoring of the manufacturing site (cleanroom environmental monitoring).
It is noted that all affected batches met specifications upon release, sterility testing of the finished product was successful and to date no adverse events associated with these batches have been reported.
This Decision is adopted as a precautionary measure in order to reinforce the voluntary recall of the producer CHIESI FARMACEUTICI SPA, ITALY and in the context of the protection of public health.
This Decision is adopted as a precautionary measure in order to reinforce the voluntary recall of the producer CHIESI FARMACEUTICI SPA, ITALY and in the context of the protection of public health.
The company CHIESI HELLAS AEBE, which has supplied the batch in question, must immediately contact the recipients and withdraw them from the market.
Documents of the recall must be kept for a period of at least five (5) years and brought to the attention of the EOF, if requested.
