Losartan G.L. Filmtabletten and Losartan-HCT G.L. - Filmtabletten
Recall
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Medicines
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22/12/2021
The marketing authorisation holder informed its customers on December 22, 2021 that laboratory analyses of the active ingredient used in the mentioned batches have revealed azido contamination above the acceptable limit.
For this reason, the affected batches are recalled.
| Name of the medicinal product | 1) Losartan G.L. 100 mg – Filmtabletten 2) Losartan G.L. 50 mg - Filmtabletten 3) Losartan-HCT G.L. 100mg/25 mg - Filmtabletten 4) Losartan-HCT G.L. 50mg/12,5 mg - Filmtabletten |
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| Marketing authorisation number(s) | 1) 1-28728 2) 1-28727 3) 1-28690 4) 1-28689 |
| CIP code | 1) 3759151 2) 3759145 3) 3759174 4) 3759168 |
| Marketing authorisation holder | G.L. Pharma GmbH |
| Batch number(s) | 1) Batch, Expiry Date 0E303B, 30.04.2025 0E304A, 30.04.2025 2) Batch, Expiry Date 0E305A, 30.04.2025 0E305B, 30.04.2025 3) Batch, Expiry Date 0E306A, 30.04.2025 0E306B, 30.04.2025 4) Batch, Expiry Date 0J358A, 31.08.2025 0J358B, 31.08.2025 0J358C, 31.08.2025 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-3728 |
Further inquiry note
Page last modified:
22/12/2021