27 Apr Sodium Fluoride 0.55mg/4 drops equivalent to 0,25 mg fluoride. (Zymafluor Oral Drops)
| Company name & Address: | Registration number | Batch (Bulk) number(s) | Expiry date | Pack size | First distributed | Re-call Classification | Recall date |
|
Viatris South Africa (Pty) Ltd 4 Brewery Street Isando, Johannesburg, 1609 |
Y/24/394 |
2304254 |
30 June 2028 |
20 ml |
28 November 2023 |
Class II Type B |
19. December.2025 |
Brief description of the problem (reason for recall)
Incomplete closure due to insufficient cap sealing, resulting in damage to the outer carton. Upon further testing it was noted the Stability Out-of-Specification Assay Result for Zymafluor.
Advise for health professionals and distributors:
We request that you refrain from selling any of the affected batch(s) of Zymafluor Oral Drops (Sodium Fluoride) Batch number: 2304254 and return them to your supplying warehouse or distributor with immediate effect. Viatris South Africa (Pty) Ltd will collect all your stock which will be credited.
For further product information, please call Viatris South Africa (Pty) Ltd on +27114511300. We thank
you in advance for your co-operation and apologise for any inconvenience caused.
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.