Mohale urged patients not to panic or stop their medication.
The South African Health Products Regulatory Authority (SAHPRA) has ordered the recall of four batches of Enalapril 10 mg Arya. Picture: Arya Pharma (Pty) Ltd
Patients using Enalapril 5mg tablets have been urged to continue their treatment as normal.
This follows confirmation that a recent recall only affected the 10mg version of the medicine.
The Department of Health moved to calm fears on Thursday. The clarification followed the South African Health Products Regulatory Authority’s (SAHPRA) recall of certain batches of Enalapril 10mg tablets.
Why the 10mg tablets were recalled
The medicine is used to treat high blood pressure and manage heart failure.
Health department spokesperson Foster Mohale said the recall did not extend to the 5mg version supplied to public healthcare facilities.
“The Department of Health wishes to reassure patients, healthcare professionals and the general public that the recent recall of Enalapril 10 mg tablets… does not affect the same product packaged at 5 mg, which is currently being supplied to public sector health facilities,” he said.
Mohale said the affected stock was manufactured by Arya Pharma.
It had only been approved as a short-term substitute while the department’s usual supplier sorted out production issues.
SAHPRA confirms 5mg tablets meet standards
“The affected tablets (Enalapril 10 mg) were only approved as a temporary alternative while the contracted supplier, Austell Pharmaceuticals, experienced a delay in releasing its Enalapril 5 mg product following quality checks by the SAHPRA,” he said.
Mohale said the department had checked with the regulator on the safety of the alternative dosage.
“The Department has confirmed with SAHPRA that the Enalapril Arya 5 mg tablets may be used and distributed in the country, and all batches supplied to the public health sector have been confirmed to meet the required quality and registration standards,” Mohale said.
Patients told not to stop treatment
Mohale urged patients not to panic or stop their medication.
“Patients using Enalapril 5 mg tablets do not need to stop taking this life-saving medicine mainly because of the recall of the 10 mg tablets,” he said.
He added that patients should keep taking their medicine as prescribed unless told otherwise by a healthcare professional.
Mohale also called on provinces and facilities to share the information with staff “to avoid unnecessary concern or disruption to patients”.
