Batches of Telmisartan/Amlodipine are recalled by the Medicines Agency (ANSM). Patients must return their boxes to the pharmacy.
Drug specialties from the laboratory Arrowused in the treatment ofhigh blood pressurecontaining the association of Telmisartan/Amlodipine substances, are recalled, indicates the Medicines Agency (ANSM) in a press release dated January 13, 2023. The reason for this recall: an error in the dosage display which could lead an underdose in patients treated with these drugs. It is indeed written the mention Telmisartan/Amlodipine Arrow 80mg/5mg on a box that contains Telmisartan/Amlodipine Arrow blister packs and tablets 40mg/5mg. These drugs combine two hypertension : telmisartan (which blocks the action of angiotensin II, a substance that causes the arteries to contract) and amlodipine (a vasodilator from the family of calcium channel blockers which enhances the action of telmisartan).
What drugs are affected by the recall?
These are the following lots:
- Telmisartan/Amlodipine Arrow 40mg/5mg, tablet – box of 90 (CIP 34009 302 227 1 3): Lot 21221 (EXP 12/2023)
- Telmisartan/Amlodipine Arrow 80mg/5mg, tablet – box of 90: Lot 21221 (EXP 12/2023)
What should the patient do who has these drugs?
“Nowadays, we have not received a statement related to this defect“, wishes to warn the ANSM. As a precaution, the agency has asked pharmacists to contact, by all means at their disposal, patients likely to hold and / or have used the batch concerned. by this recall. All patients are also asked to return to their pharmacy the boxes and blisters of the batch 21221 (exp 12/2023) of the specialties described above. A box from another batch will be delivered free of charge by the pharmacy to the patient in exchange for his box.
Source : Telmisartan/Amlodipine Arrow 40 mg/5 mg and 80 mg/5 mg tablet – Recall of batch no. 21221, ANSM, January 13, 2023.