The Spanish Agency for Medicines and Health Products (Aemps) has ordered the withdrawal of several affected batches of an antibiotic commonly used to treat respiratory, ear, skin and urine infections.

Among these bacterial infections are acute bacterial sinusitis, acute bacterial otitis media, pharyngitis, tonsillitis, pneumonia or uncomplicated urethritis, and cervicitis.

As the agency has detailed, these are nine batches of Azithromycin Alter 500mg EFG film-coated tablets, manufactured by Alter Laboratories.

The Aemps has clarified that the withdrawal of the Azithromycin units responds to a “Quality defect that does not pose a serious or vital risk for the patient”.

lots affected

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 12/30/2024

Lot V001B, expiration date 03/30/2025

Lot V002A, expiration date 03/30/2025

Lot V003A, expiration date 03/30/2025

Lot V008A, expiration date 09/30/2025

Side effects

Side effects of this drug include diarrhea, headache, vomiting, abdominal pain, nausea, or changes in the number of some types of white blood cells and bicarbonate in the blood.

This alert comes a few months after Health urgently withdrew drugs for osteoporosis due to “a out-of-spec result in the cholecalciferol titration trial”.