Swiss drugmaker Acino is questioning a recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use to recall its blood pressure treatments containing the API clopidogrel. The company says in an statement that the inspectors who conducted the audit of its API supplier, Glochem Industries in Visakhapatnam, India, "explicitly stated that there is no necessity for a recall recommendation."
The CHMP recommended the recall a week ago, and forwarded its advice to the European Commission for legal confirmation.
The inspection did reveal GMP deviations, Acino concedes, but on-site inspectors recorded no quality deficiencies concerning the clopidogrel products. Risk assessment and analysis confirmed product quality, the company says.
The company also says that it has an alternate source of the API and will restart shipments shortly.
- see the Acino statement
- here's the EMEA recall recommendation