AIFA, the Italian Medicines Agency, has prepared specific measures for the recall of batches of multiple products. Let’s find out the brands involved.
Market withdrawals not only involve food but also medicines. Attention must be high to avoid even serious health problems. For this reason we highlight the latest recalls made known by AIFA.
The Italian Medicines Agency deals with the regulatory activity of medicines in our nation. The organization operates autonomously, transparently and cost-effectively under the direction of the Ministry of Health and the supervision of the Ministry of Economy. AIFA’s objectives include guaranteeing access to the drug and safe use as a health defense tool, ensuring innovation, efficiency and simplification of procedures especially for drugs aimed at treating rare diseases.
Among AIFA’s obligations there is also that of report quality defects of medicines, market withdrawals and discontinuations of previously authorized medicines. With safety communications, therefore, the Agency informs citizens of any dangers linked to various reasons such as defects in the composition of a medicine. The citizen himself can report to AIFA an adverse reaction or other problem encountered that was not previously known.
The latest withdrawals reported by AIFA
The Italian Medicines Agency has arranged for the withdrawal of several batches of an anti-inflammatory from the company IBN Savio Srl (Pomezia, via del Mare 36). The medicine in question is DECADRON 2 mg/ml oral drops sold in the 10 ml bottle. The affected lots are
- W231026 expiring October 2025,
- W230856 expiring August 2025,
- W230532 expiring May 2025,
- W230490 expiring May 2025,
- W231025 expiring October 2025,
- W230866 expiring August 2025.
The recall also affected the packs of 2 mg/ml oral drops with lot numbers W231054 (expires October 2025), W230881 (expires September 2025) and W231055 (expires October 2025). Reason for the recall a notification from the AIV holder on a out of specification detected in stability analysis of the drug used, let us remember, to treat degenerative arthrosis, chronic evolutionary polyarthritis, asthmatic conditions and dermatitis.
The second recall concerns two batches of a medicine aimed at controlling levels of parathyroid hormone, calcium and phosphorus. The drug is produced by the company Dr Reddy’s Srl (Milan, Via L. Settala 20). The medicine is Cinacalcet Dr. Reddy’s 30 mg film-coated tablets, batch number B2201448 expiring in March 2025 and B2203080 expiring July 2025. Reason for withdrawal from the market the company’s notification regarding the presence of nitrosamine impurity beyond the limits permitted by law. Cinacalcet is used to treat diseases caused by problems with the parathyroid glands.
