New health alert in Spain. In this case, the Spanish Agency of Medicines and Health Products (Aemps) has ordered the withdrawal of six batches of Irbesartan Combix, a drug for hypertension.
The reason for the recall was that an impurity has been detected above the permitted limit in this drug to reduce blood pressure. The affected batches are as follows:
- IRBESARTAN COMBIX 300 mg EFG FILM COATED PILLS , 28 tablets (NR: 74943, CN: 685373).
- Lot: M000689, expiration date 31/03/2023
- Lot: M012157, expiration date 30/11/2023
- IRBESARTAN COMBIX 75 mg FILM COATED TABLETS EFG, 28 tablets (NR: 74941, CN: 685371)
- Lot: M010064, expiration date 07/31/2023
- Lot: M100406, expiration date 01/31/2024
- IRBESARTAN/HYDROCHLOROTHIAZIDE COMBIX 150 mg/12.5 mg FILM COATED TABLETS EFG, 28 tablets (NR: 75735, CN: 688986)
- Lot: M011549, expiration date 31/08/2022
- IRBESARTAN/HYDROCHLOROTHIAZIDE PHARMA COMBIX 300 MG/25 MG FILM COATED PILLS EFG , 28 tablets (NR: 77771, CN: 698714)
- Lot: M015999, expiration date 30/11/2022
The AEMPS has communicated the withdrawal from the market of all the units distributed of the affected lots and their return to the laboratory through the usual channels.
This drug is distributed in film-coated tablets and is used for the treatment of hypertension.
The Aemps has classified the defect as class 2. Drug quality defects are classified into three classes (1, 2 and 3), with class 1 corresponding to a higher potential risk and class 3 corresponding to a lower risk.
The AEMPS will be pending the withdrawal of the drug.
The Spanish Agency of Medicines and Health Products (AEMPS) has indicated that precautionary measures will be taken, such as the withdrawal from the market of all the units distributed of the affected batches of this drug for hypertension. As well as the return to the laboratory through the usual channels.
Likewise, he has been able to confirm that he will be monitoring the withdrawal of the six batches of the drug Irbesartan Combix, which will depend on each Autonomous Community. This drug for hypertension is very popular.
The Spanish Agency of Medicines and Health Products, formerly called AGEMED, is a state agency of Spain created by Law 66/1997 of December 30, with the status of an autonomous organism until 2011 and thereafter as a state agency. Its competencies were extended by Law 50/1998
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