27 Apr Hetovanil 62,5 / 25 mg & 250 / 100 mg
| Company name & address | Product | Registration number | Batch number(s) | Expiry date | Pack size | First distributed | Re-call Classification | Recall date |
| HETERO DRUGS SOUTH AFRICA (PTY) LTD
Waterfall Corporate Campus, Building No. 2 First Floor74 Waterfall Drive |
Hetovanil 62,5 / 25 mg |
48/20.2.6/0526
|
FD243828A |
09/2026 |
12s PVC ALU/BLISTER |
10 Dec 2024 |
Class II Type C |
30.June.2025 |
| Hetovanil
250 / 100 mg |
48/20.2.6/0527 | ATP24014C | 03/2026 | 12s PVC ALU/BLISTER |
13 Sept 2024 |
Class II Type C | 30.June.2025 |
Brief description of the problem (reason for recall)
This recall is initiated because the professional information and patient information leaflet on the Afrikaans text incorrectly states “Twee HETOVANIL 62,5/25 mg-tablette as ’n enkele dosis daagliks.” instead of “Drie HETOVANIL 62,5/25 mg- tablette as ’n enkele dosis daagliks.” for 31 – 40 kg, as it is correctly stated on the English side of the professional information under dosage in children.
Advice for health professionals and distributors
We request that you refrain from selling the affected batches of Hetero Drugs Limited Hetovanil 62,5 / 25 mg as well as Hetovanil 250 / 100 mg and return them to your supplying warehouse or distributor with immediate effect. Hetero Drugs SA will collect all your stock which will be replaced.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points, and the recall process was 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.