Arya Pharma has recalled four batches of its high blood pressure medication, Enalapril 10mg Arya. The South African Health Products Regulatory Authority (Sahpra) initiated the recall after post-marketing surveillance inspections identified results that failed to meet specifications.
Arya Pharma is implementing the Class II Type A recall in consultation with Sahpra, in accordance with the Medicines and Related Substances Act 101 of 1965, as amended.
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 batches include: |
| Product | Batch/Lot | Pack Size | Manufacturing Date | Expiry Date |
| Enalapril 10 mg Arya | GQQ24053 | 28s | September 2024 | August 2026 |
| Enalapril 10 mg Arya | GQQ24064 | 28s | October 2024 | September 2026 |
| Enalapril 10 mg Arya | GQQ24066 | 28s | October 2024 | September 2026 |
| Enalapril 10 mg Arya | GQQ24067 | 28s | October 2024 | September 2026 |
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.
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.
