27 Apr LOSAAR PLUS 50/12.5 TABLETS 30’S (losartan 50 mg, hydrochlorothiazide 12,5 mg) and LOSAAR PLUS 100/25 TABLETS 30’S (losartan 100 mg, hydrochlorothiazide 25 mg)
| Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
|
Accord Healthcare (Pty) Ltd, Building 2, Tuscany Office Park 6 Coombe Place, Johannesburg, South Africa |
50/12.5mg: 42/7.1.3/0325 |
01523, 000919, 000920, 01870 |
May 2023 Jul 2023 |
30 |
July 2020 |
Class II Type B |
6 October 2021 |
| 100/25 mg:
46/7.1.3/0715 |
00915, 00916,
00917, 00918 |
May-2023 | 30 | July 2020 | Class II Type B | 6 October 2021 |
Reason for recall
The products are being recalled due to quality defect: The company initiated an immediate recall of the following batches of the products, as listed above, following the detection of an azido impurity in the losartan active ingredient. The impurity, also known as 4-chloro azido methyl tetrazole is formed during the manufacture of the active ingredient.
Advice to HCPs/Distributors/Public:
Healthcare professionals are urged to return all stock on hand of the above batches of LOSAAR PLUS 50/12,5 and LOSAAR PLUS 100/25 to their relevant distributor and/or wholesaler as soon as possible for reimbursement. Please retain this letter in a prominent position for at least one month in case of stock in transit.
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.