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:
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Lot S001A, expiration date 06/30/2023.
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Lot S002A, expiration date 06/30/2023
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Lot S003A, expiration date 06/30/2023
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Lot S004A, expiration date 06/30/2023
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Lot T001A, expiration date 30/12/2024
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Lot V001B, expiration date 30/03/2025
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Lot V002A, expiration date 03/30/2025
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Lot V003A, expiration date 03/30/2025
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Lot V008A, expiration date 30/09/2025
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