27 Apr Monofer 500mg/5ml (Iron (III) isomaltoside)
|
Company name & Address: |
Registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
Date Published |
| Acino Pharma (Pty) Ltd, No 106, 16th Road, Midrand, 1686, Gauteng, South Africa | 46/8.3/0167 | 230504A-5 |
May 2026
|
5ml (5 vials per carton) |
16 May 2024
|
Class III Type B | 16 September 2024 | 14 October 2024 |
Reason for recalls
This recall is initiated as a result of a customer complaint reported within Poland. The customer complaint relates to a glass piece found in one (1) vial.
Advice to HCPs/Distributors/Public
You are requested to take the following action with regards to the affected batch:
- Return the affected product to your supplying distributor/wholesaler for a credit.
- If any of the recalled stock could have been transferred from your hospital to another, please inform them of this recall alternatively inform Acino and provide us with their details
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.