Ondansetron HCL 4mg tablet (Zothena 4 mg)

Brief description of the problem (reason for recall)

This recall is initiated following the discovery of Zothena 4 mg cartons containing Zothena 8 mg foil packs (8 mg foil packs were mistakenly placed inside the 4 mg cartons).

Advise for health professionals and distributors:

Eurolab (Pty)Ltd request that you return the affected product to your supplier or wholesaler for a credit. If any of the recalled stock has been transferred/sold from your hospital or healthcare facility to another, please inform them of this recall immediately, or alternatively, notify Eurolab at once, and kindly provide us with their details so we can inform them of the recall.

Adverse reactions or any additional details, please email info@eurolab.co.za  or melani@eurolab.co.za  or SAHPRA.

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated. A rapid alert was also shared with PIC’s member countries.

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.