In agreement with the National Medicines Safety Agency (ANSM), the Opella Healthcare France laboratory announces the withdrawal of three batches of the specialty Maxilase sore throat alpha-amylase 3000 U. CEIP, coated tablet.
The three lots concerned are as follows:
Lot n° 31271 – expiry 09/2025
Lot n° 31272 – expiry 09/2025
Lot n° 31273 – expiry 09/2025
This precautionary measure follows “to the demonstration of a result below the specifications for the alpha-amylase content observed during the stability studies of these batches. This is the only non-compliant parameter observed.” As specified on the ANSM website, “other lots of Maxilase sore throat alpha-amylase 3000 U. CEIP, coated tablet, currently on the market are not impacted by the defect”. The manufacturer specifies that it has not received no complaints or pharmacovigilance cases in relation to this defect at the moment.
For any medical questions, Opella Healthcare France provides professionals with a free number for mainland France and the DROM-COM: 0801 907 577.
France
