27 Apr Lasix 80 mg tablets (furosemide 80 mg)
| Company name & Address | registration number | Batch number(s) |
Expiry date(s) |
Pack size | First distribution date |
Re-call Classification |
Recall date |
|
Sanofi Aventis South Africa (Pty) Ltd/Zentiva Pharmaceuticals (Pty) Ltd 5th Floor Building I Hertford Office Park 90 Bekker Road Vorna Valley, Midrand
|
V/18.1/9 |
CG022A |
12/2023 |
30s |
22/04/2022 |
Class II Type C
|
17.Oct.2022 |
Reason for recall
Sanofi Aventis South Africa (Pty) Ltd took the decision to initiate a voluntary recall on Lasix tablets 80 mg. The recall is instituted following the detection of a dissolution failure at the 6 months testing interval. The results for dissolution were below the required 80% after 60 minutes.
Advice to HCPs/Distributors/Public:
The company requests and urges their customers to return all stock on hand of Lasix 80mg tablets 30s, batch: CG022A to their relevant distributor and/or wholesaler as soon as possible for reimbursement.
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.