27 Apr DERMADINE ORAL ANTISEPTIC solution (Povidone-iodine 1,00 g (1 % m/v))
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Cipla Medpro (Pty) Ltd, Cipla Head Office, Parc du Cap, Building 9, Mispel Street, Bellville, Bellville,Cape Town, 7530, South Africa |
H1511 (Act 101/1965) |
120983 |
October 2022 |
200 ml |
September /2020 |
Class III Type C |
24 January 2022 |
Reason for recall
This product is being recalled due to a complaint relating to quality defect: The impacted batch of Dermadine Oral antiseptic solution was deemed to be defective and did not comply with the requirements of Act 101 of 1965 in terms of the product specification, Solution is clear – no iodine colour, smell or taste, (lack of efficacy).
Advice to HCPs/Distributors/Public:
Please refrain from selling or dispensing this batch. Stock of the affected the batch is re-called from the wholesalers and direct retailers, including cross- border customers, utilising company representatives.
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.