Health issues an alert related to a famous diabetes medication.The Spanish Agency for Medicines and Health Products (Aemps) has published a health alert related to one of the most used medications in the treatment of diabetes, and more specifically type 2. It is sitagliptin/metformin Normon, prescribed to help lower blood sugar levels in patients with type 2 diabetes.
The Aemps, dependent on the Ministry of Health, details in the alert issued that the identified problem consists of the presence of impurities above the established limit, which represents a quality defect.Although this circumstance does not imply a life-threatening risk for the patient, it does require the preventive removal of all affected units to guarantee the safety and quality of the medication.
Affected lots and expiration dates
Lot: A25A1, expiration date 02/28/2027
Lot: A25C1, expiration date 02/28/2027
Lot: A2581, expiration date 02/28/2027
Lot: A2591, expiration date 02/28/2027
Lot: A27X1, expiration date 02/28/2027
Lot: A2801, expiration date 02/28/2027
Lot: A6MK2, expiration date 06/30/2027
Lot: A6ML1, expiration date 06/30/2027
Lot: A6MM1, expiration date 06/30/2027
Lot: A6MN1, expiration date 06/30/2027
Lot: XCKU1, expiration date 11/30/2026
Batch: XCKV1, expiration date 11/30/2026
Lot: XCKX1, expiration date 11/30/2026
Lot: X0RA1, expiration date 01/31/2026
Lot: X0R91, expiration date 01/31/2026
Lot: X1HX1, expiration date 02/28/2026
Lot: X5UF1, expiration date 05/31/2026
Batch: X60J1, expiration date 05/31/2026
Lot: X61X1, expiration date 05/31/2026
Lot: X86M1, expiration date 07/31/2026
Batch: X86N1, expiration date 07/31/2026
Batch: X86P1, expiration date 07/31/2026
Batch: X86R1, expiration date 07/31/2026
The 23 affected lots of this medicine belong to Normon.
Health has reported the problem after confirming a quality defect in various batches of the medication distributed in pharmacies, which consists of the presence of impurities above the established limit.After this, the Aemps has activated the withdrawal procedure and has notified of the need to return all the distributed units of the affected batches.
Pharmacies must immediately withdraw the affected batches, stop dispensing them and return them to the laboratory through the usual channels.Patients who have a container included in this alert at home should go to their pharmacy for the corresponding management.
The affected medicine helps lower blood sugar in patients with type 2 diabetes. Sitagliptin/metformin Normon contains two different medicines, called sitagliptin and metformin.
Health has already communicated the alert to the health authorities of all the autonomous communities, who must supervise the withdrawal process.Pharmacies and distribution services must pick up and return affected units as quickly as possible.For their part, patients should check the lot number on their container and go to their pharmacy if it matches any of the recalled ones.
