27 Apr Lumont 10 mg tablets (montelukast)
| Company name & Address | registration number | Batch number(s) |
Expiry date(s) |
Pack size | First distribution date |
Re-call Classification |
Recall date |
|
Zydus Healthcare SA (Pty) Ltd. Southdowns Office Park, 22 Karee Street, Centurion, 0157
|
4/10.2.2/0792 |
108011 |
31/05/2024
|
30s |
30/08/2021 |
Class II Type B
|
17.Oct.2022 |
Reason for recall
Zydus Healthcare SA (Pty) Ltd took the decision to initiate a voluntary recall on Lumont 10 mg tablets. The recall is instituted due to out of specification results observed in dissolution test at 12 Month(s) time point interval in long term condition i.e., 30°C/75% RH.
Advice to HCPs/Distributors/Public:
The company requests all customers to refrain from selling or dispensing stock from the affected batch. Undistributed stock on hand placed on quarantine with immediate effect. All affected returned stock will be replaced free of charge.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall 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.