Semaglutide (API)

Reason for recall

Marsing & Co. Africa (Pty) Ltd, took the decision to initiate a recall of the batch 23022832. The recall was due to the importation of unauthorised substance (API) not included on the product list as per Section 22C (1)(b) Licence. In addition, this recall is initiated because the substance has not been evaluated or registered in South Africa thus safety, efficacy and quality of the substance and any products compounded containing this substance have not been established by SAHPRA. The semaglutide, said to be found in this unauthorised substance, may contain unexpected impurities or degradation products which can have unknown effects on patients using this unevaluated substance.

Advice to HCPs/Distributors/Public:

The company requested their clients to refrain from dispensing this API, Batch No. 23022832 and to return all remaining stock to their supplying warehouse or distributor with immediate effect

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process has been initiated.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.