Losartan 1A Pharma und Losartan-HCT 1A Pharma – Filmtabletten
Recall
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Medicines
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21/09/2021
The marketing authorisation holder informed its customers on September 21, 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 1A Pharma 100 mg/25 mg – Filmtabletten 2) Losartan-HCT 1A Pharma 50 mg/12,5 mg - Filmtabletten 3) Losartan 1A Pharma 50 mg – Filmtabletten |
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Marketing authorisation number(s) | 1) 1-28476 2) 1-28475 3) 1-27051 |
CIP code | 1) 3549206 2) 3549181 3) 3515880 |
Marketing authorisation holder | 1A Pharma GmbH |
Batch number(s) | 1) batches, expiry date KK6130, 12.2021 KN7055, 02.2022 KT4300, 05.2022 LK3470, 04.2023 2) batches, expiry date KK7451, 12.2021 KN7082, 02.2022 KW6096, 07.2022 3) batches, expiry date KC2273, 07.2022 KM5236, 02.2023 LG2587, 02.2024 LG2588, 02.2024 LG2589, 02.2024 |
Classification of the recall | 2 |
Depth of recall | Pharmacies |
BASG reference number | INS-640.001-3634 |