Losartan 1A Pharma und Losartan-HCT 1A Pharma – Filmtabletten

Recall | Medicines | 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
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 recall2
Depth of recall Pharmacies
BASG reference number INS-640.001-3634
Email

Further inquiry note