Spanish health authorities order recall of several batches of well-known antidepressant
The authority detected an impurity above an established limit ·
The Spanish agency for medicines and health products (Aemps) has ordered the withdrawal of several batches of a well-known antidepressant used to treat anxiety disorders, depressive disorders and diabetic peripheral neuropathic pain, after detecting an impurity above the established limit.
The product concerned is Duloxetine Pensa Pharma 60mg in the form of hard gastro-resistant capsules EFG, marketed by Towa Pharmaceutical Europe, S.L.
Specifically, the Aemps has withdrawn from the market all units of: Duloxetine Pensa Pharma 60mg gastroresistant hard capsules EFG, 28 capsules (Blister PVC/PVDC-ALUMINIUM) (NR: 79371, CN: 704751) Batch: 231441, expiry date 30/06/2026; and Duloxetine Pensa Pharma 60mg gastroresistant hard capsules EFG, 56 capsules (PVC/PVDC-Aluminium) (NR: 79371, CN: 706553) Lot: 231514, expiry date 31/05/2026 and Lot: 240603, expiry date 30/11/2026.
Patients taking this medicine should check whether they have one of the affected batches. If they do, they should return them. However, the health authorities have assured that these batches do not pose a life-threatening risk to patients.
