The South African Health Products Regulatory Authority (SAHPRA) has announced the immediate recall of compounded Semaglutide, Tirzepatide and combined Semaglutide/Tirzepatide products.
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The medicines were manufactured by iDEXIS (Pty) Ltd, operating as Sentra Pharmacy in Silverton, Pretoria.
The recall follows an investigation by SAHPRA and the South African Pharmacy Council in May.
Semaglutide is prescribed to treat type 2 diabetes, support weight management, and reduce cardiovascular risk, while Tirzepatide is used to treat type 2 diabetes, obesity and obstructive sleep apnoea in people with obesity.
During the inspection, regulators identified potential serious safety concerns relating to the products.
To safeguard public health, SAHPRA seized all Semaglutide, Tirzepatide and combination products found at the pharmacy during the inspection.
The regulator has also ordered the recall of all affected products that have already been distributed to patients and healthcare providers.
While several batch numbers have been identified, SAHPRA warns that additional unlisted batches may also be affected because they were distributed before the inspection.
Among the recalled products are Tirzepatide pens in 5mg, 10mg and 15mg strengths, as well as Semaglutide pens in 0.5mg, 1mg and 2mg strengths.
The affected products have been classified as Class I Type A recalls, the most serious category of medicine recall, indicating a potential risk of severe health consequences.
SAHPRA has urged pharmacies, healthcare professionals and patients who have any of the recalled products to stop using or dispensing them immediately.
The medicines should be returned to the pharmacy or healthcare provider that supplied them.
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