The South African Health Products Regulatory Authority (SAHPRA) has issued an immediate recall of compounded Semaglutide, Tirzepatide and combination Semaglutide/Tirzepatide medicines manufactured by Sentra Pharmacy, citing serious safety concerns.
The affected products were produced by iDEXIS (Pty) Ltd, trading as Sentra Pharmacy in Silverton, Pretoria.
The recall follows a joint inspection conducted by SAHPRA and the South African Pharmacy Council in May, during which regulators identified potential risks associated with the medicines.
Semaglutide is commonly prescribed to treat type 2 diabetes, assist with weight management and reduce the risk of cardiovascular disease. Tirzepatide is used to treat type 2 diabetes and obesity and may also be prescribed for people with obesity who have obstructive sleep apnoea.
Following the inspection, SAHPRA seized all stocks of Semaglutide, Tirzepatide and combination products found at the pharmacy as a precautionary measure to protect public health.
The regulator has also ordered the recall of all affected products that have already been supplied to patients and healthcare providers.
While several batch numbers have been identified, SAHPRA warned that additional batches not listed in the recall may also be affected, as they were distributed before the inspection took place.
The recall includes Tirzepatide injection pens in 5mg, 10mg and 15mg strengths, as well as Semaglutide injection pens in 0.5mg, 1mg and 2mg strengths.
SAHPRA has classified the action as a Class I Type A recall the highest level of medicine recall indicating that the products may pose a risk of serious or life-threatening health consequences.
The regulator has urged pharmacies, healthcare professionals and patients to immediately stop dispensing or using the recalled medicines.
Patients in possession of any of the affected products have been advised to return them to the pharmacy or healthcare provider from whom they were obtained.
SAHPRA said the recall forms part of its ongoing efforts to ensure that medicines available in South Africa meet the required standards of quality, safety and efficacy.