The affected drug is sold in three different formats, whose defective batches have been withdrawn according to Aemps
The Ministry of Health has alerted this Tuesday about the withdrawal of several batches of a medicine that is used to treat the anxiety and depression. According to the Spanish Agency for Medicines and Health Products (Aemps), an impurity above its established limit has been detected.
The affected product is Duloxetina Sandoz in capsule formats of 30 and 60 milligrams and in packages of 28 and 56 capsules. The marketing authorization belongs to Sandoz Farmacéutica and its manufacturer is Laboratorios Lesvi.
According to the drug’s package insert, it is used in adults to treat depression and generalized anxiety disorder. Also, the drug is used for the treatment of diabetic neuropathic pain.
DULOXETINE SANDOZ 30 MG EFG GASTRO-RESISTANT HARD CAPSULES, 28 capsules (NR: 79569, CN: 705511)
Batch: R77, expiration date 01/31/2024
Batch: R975, expiration date 04/30/2024
Lot: S0024, expiration date 01/31/2025
Batch: S0595, expiration date 04/30/2025
DULOXETINE SANDOZ 60 MG GASTRORESISTANT EFG HARD CAPSULES, 28 capsules (NR: 79570, CN: 705512)
Batch: R1214, expiration date 07/31/2024
Batch: R76, expiration date 12/31/2023
Batch: S0482, expiration date 03/31/2025
DULOXETINE SANDOZ 60 MG GASTRORESISTANT EFG HARD CAPSULES 56 capsules (NR: 79570, CN: 729570)
Batch: R1073, expiration date 04/30/2024
Batch: R133, expiration date 12/31/2023
Lot: S0199, expiration date 01/31/2025
The Aemps, dependent on the Ministry of Health, has indicated that the market withdrawal of all the distributed units of the affected batches and return to the laboratory through the usual channels.
Likewise, the agency has ensured that the “quality defect does not pose a serious or vital risk for the patient” and classifies the alert as class 2.
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