Losartan ratiopharm Filmtabletten

Recall | Medicines | 02/09/2021

The marketing authorisation holder 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 ratiopharm 50 mg Filmtabletten
2) Losartan ratiopharm 100 mg Filmtabletten
Marketing authorisation number(s) 1) 1-27321
2) 1-27322
CIP code 1) 392374
2) 3912380
Marketing authorisation holder Teva B.V.
Batch number(s) 1) Batch, Expiry Date
0621020, 31.10.2023
0480820, 31.08.2023
0350520, 31.05.2023
0110320, 31.03.2023
0750120, 31.01.2023
0790619, 30.06.2022
2) Batch, Expiry Date
1410820A, 31.08.2023
1410820, 31.08.2023
1090520, 31.05.2023
1580220, 28.02.2023
1590220, 28.02.2023
1311219, 31.12.2022
1031118, 30.11.2021
1590918, 30.09.2021
Classification of the recall2
Depth of recall Pharmacies
BASG reference number INS-640.001-3632
Email

Further inquiry note