Arya Pharma has recalled four batches of its high blood pressure medication, Enalapril 10mg Arya, after quality concerns.
The South African Health Products Regulatory Authority (Sahpra) initiated the recall after post-marketing surveillance inspections identified results that failed to meet specifications.
Sahpra has urged patients, healthcare professionals, pharmacies, wholesalers and other medicine suppliers to immediately check their stock, identify any affected batches and take the necessary action in line with the recall.
The affected batch numbers are:
- GQQ24053
- GQQ24064
- GQQ24066
- GQQ24067
What is Enalapril?
Enalapril is used to manage high blood pressure. Sahpra has asked patients currently taking Enalapril 10 mg Arya to check the batch number on their medicine packaging to determine whether their medicine is affected.
SAHPRA spokesperson Rodgers Baloyi says pharmacies and suppliers have been told to stop selling or distributing the affected batches and return them through the proper supply chain.
“If you use this medicine, please check the batch number on your packaging. If you have an affected batch, speak to your doctor or pharmacist, who will advise you on what to do next. Most importantly, do not stop taking your medicine without first getting medical advice.”
Patients who have one of the affected batches have been advised to contact their pharmacist or healthcare professional for advice and, where necessary, to request an alternative medicine.
Sahpra added that patients should not stop taking their blood-pressure medication without first consulting their doctor, pharmacist or another healthcare professional. Sahpra emphasised that the recall applies only to the four identified batches.
Healthcare professionals, pharmacies, wholesalers and other medicine suppliers are requested to:
- Immediately identify stock from the affected batches.
- Stop dispensing, selling or distributing the affected batches and quarantine affected stock.
- Return affected stock through the established supply chain in accordance with the recall instructions issued by Arya Pharma (Pty) Ltd.
