Infarmed ordered the recall of two batches of the drug Ramipril + Hydrochlorothiazide Generis, used in cases of high blood pressure, because out-of-specification values were detected in the dosage and impurity parameters.
According to the National Authority for Medicines and Health Products, batches 21LN083A (56 tablets), valid until 01/12/2023, and 22AN092A (56 tablets), valid until 01/01/2024, have been recalled.
Infarmed also says that entities that have these batches of medicine in ‘stock’ cannot sell, dispense or administer them and must return them.
It also advises patients who are using medicines belonging to these batches not to stop treatment but, as soon as possible, to ask for a replacement with another batch or ask their doctor or pharmacist for an alternative medicine.
The marketing authorization holder for Ramipril + Hydrochlorothiazide Generis (2.5 mg + 12.5 mg and 5 mg + 25 mg) is Generis Farmacêutica, S.A..
