EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP):
- R0-CEP 2009-267-Rev 00 / Erythromycin
The manufacturers concerned are:
Mehta API Pvt. Ltd.
Behind Remi Group, Near Plot No. N-211
Village Kumbhavli, Adjacent to M.I.D.C. Area
Boisar, Taluka Palghar, District Thane
India-401 506 Boisar, Maharashtra
If the EDQM withdraws or suspends a CEP, the marketing authorisation holder must take the necessary measures to ensure that active substances from the concerned active substance manufacturer are not used, either permanently or for a defined period.
If any medicines on the market contain this active substance from the concerned active substance manufacturer, the marketing authorisation holder must report the product defect to the Danish Medicines Agency at rapidalert@dkma.dk.
You can find more information at the EDQM’s website via the box to the right.
