The EDQM has suspended the Certificates of Suitability for the active substances metronidazole and caffeine
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the Certificates of Suitability (CEP) for the active substances metronidazole (R1-CEP 2002-119-Rev 00) and caffeine (R0-CEP 2005-116-Rev 01).
The manufacturer concerned is:
Tianjin Zhongan Pharmaceutical Co ltd
188 Fukang Road
China-300 384 Tianjin
If the EDQM withdraws or suspends a Certificate of Suitability (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 these active substances from the concerned active substance manufacturer, the marketing authorisation holder must report the product defect to the Danish Medicines Agency at email@example.com.
You can find more information at the EDQM's website via the factbox to the right.
Danish Medicines Agency, 12 November 2010
Created 16 November 2010