27 Apr Mizart 80 mg tablets (telmisartan 80 mg)
| Company name & Address | registration number | Batch number(s) |
Expiry date(s) |
Pack size | First distribution date |
Re-call Classification |
Recall date |
|
Viatris South Africa (Pty) Ltd 4 Brewery Street Isando, Gauteng, 1609
|
45/7.1.3/0607 |
8130141
|
10/2024
|
30s |
08/03/2022 |
Class II Type B
|
10.Oct.2022 |
Reason for recall
Viatris South Africa (Pty) Ltd took the decision to initiate a voluntary recall on Mizart 80 mg tablets. This recall is initiated in view of a complaint received, regarding comingling of tablets in a securi-tainer of Mizart 80 mg (30’s).
Advice to HCPs/Distributors/Public:
The company requested customers to refrain from selling Mizart 80mg tablets of the affected batch (batch nr. 8130141) and return it to their supplying warehouse or distributor with immediate effect. The applicant confirmed that they will ensure that the stock of batch 8130141 is replaced to their customers.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.
Reporting side effects
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