The Spanish Agency for Medicines and Health Products (Aemps) has ordered the withdrawal of nine batches of Azithromycin Alter 500mg film-coated tablets EFG, manufactured by Laboratorios Alter. Specifically, this antibiotic is commonly used to treat respiratory, ear, skin and urinary infections.
The request is made for a quality defect that does not pose a serious or life-threatening risk to the patient. Specifically, these batches have errors in the package inserts.
The Aemps, under the Ministry of Health, requests that the batches return to the laboratories and instructs the autonomous regions to follow up.
These are the batches:
Lot S001A, expiration date 06/30/2023.
Lot S002A, expiration date 06/30/2023
Lot S003A, expiration date 06/30/2023
Lot S004A, expiration date 06/30/2023
Lot T001A, expiration date 30/12/2024
Lot V001B, expiration date 30/03/2025
Lot V002A, expiration date 03/30/2025
Lot V003A, expiration date 03/30/2025
Lot V008A, expiration date 30/09/2025