Losartan/HCT ratiopharm GmbH Filmtabletten
Recall
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Medicines
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03/09/2021
The distribution partner informed its customers on September 02, 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/HCT ratiopharm GmbH 50/12,5 mg Filmtabletten 2) Losartan/HCT ratiopharm GmbH 100/25 mg Filmtabletten |
|---|---|
| Marketing authorisation number(s) | 1) 1-27217 2) 1-27220 |
| CIP code | 1) 3918075 2) 3918081 |
| Marketing authorisation holder | ratiopharm Arzneimittel Vertriebs-GmbH |
| Distributor | Rivopharm Limited / Sigmapharm Arzneimittel GmbH |
| Batch number(s) | 1) 2080620, 2090620 (Expiry Date 30.06.2022) 2) 3110520, 3120520, 3140520 (Expiry Date 31.05.2022) |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-3633 |
Further inquiry note
Page last modified:
03/09/2021