Friday, February 3

The Spanish Medicines Agency withdraws several batches of Irbesartan Combix for high blood pressure


The Spanish Agency for Medicines and Health Products (AEMPS) has issued a recall alert for six lots of the product Irbesartan Combix, indicated for the high blood pressure treatment (essential hypertension) and to protect the kidney in patients with high blood pressure, type 2 diabetes and with clinical evidence of impaired kidney function, as indicated in its package insert.

The reason for withdrawal, according to the AEMPS, is the “detection of an impurity in the active ingredient irbesartan above its accepted limit”, without the seriousness of this fact having transpired.

name and presentation

His name is Irbesartan Tablets, is manufactured by CADILA HEALTHCARE LIMITED (Sarkhej-Bavla N:H:N 8A, Moraiya, Tal; Sanand, District Ahmedabad, Gujarat State, 382-210, India) and is distributed by the company Combix, based in Pozuelo de Alarcón .

Irbesartan Tablets It is presented on the market in the following formulations:

  • Irbesartan Combix 300 mg film-coated tablets EFG, 28 tablets (NR: 74943, CN: 685373)
  • Irbesartan Combix 75 mg film-coated tablets EFG, 28 tablets (NR: 74941, CN: 685371)
  • Irbesartan/Hydrochlorothiazide Combix 150 mg/12.5 mg film-coated tablets EFG, 28 tablets (NR: 75735, CN: 688986)
  • Irbesartan/Hydrochlorothiazide Pharma Combix 300 mg/25 mg film-coated tablets EFG, 28 tablets (NR: 77771, CN: 698714)

Precautionary measures adopted

The AEMPS has thus decreed the withdrawal from the market of all the distributed units of the affected batches and their return to the laboratory through the usual channels.

The affected batches are:

Irbesartan Combix 300mg EFG film-coated tablets, 28 tablets (NR: 74943, CN: 685373)

  • Lot: M000689, expiration date 03/31/2023
  • Lot: M012157, expiration date 11/30/2023

Irbesartan Combix 75mg EFG film-coated tablets, 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 EFG film-coated tablets, 28 tablets (NR: 75735, CN: 688986)

  • Lot: M011549, expiration date 08/31/2022

Irbesartan/Hydrochlorothiazide Pharma Combix 300 mg/25 mg EFG film-coated tablets, 28 tablets (NR: 77771, CN: 698714)

  • Lot: M015999, expiration date 11/30/2022

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