Friday, September 17

The Medicines Agency orders the withdrawal of three batches of a product to treat prostate problems


The Spanish Agency for Medicines and Health Products (AEMPS) today ordered the withdrawal of the following three batches of Alfuzosin Teva 5 mg, EPG prolonged-release tablets, in boxes of 60 tablets:

  • Batch: V08540A, expiration date 03/31/2022
  • Batch: W06660B, expiration date 02/28/2023
  • Batch: W16689A, expiration date 07/31/2023

The reason put forward

The AEMPS is based to order the withdrawal on the “possible obtaining of an out-of-specification result in the dissolution test before the end of its validity period.” That is, an abnormal result in further analysis.

Is it a serious defect?

The defect is classified by the AEMPS as Class 2. Quality defects are classified into three classes (1, 2 and 3), class 1 being the one with the highest possible risk and class 3 being the one with the lowest risk.

What should I do?

If you are a patient undergoing treatment with a drug affected by an alert, check if the batch number on the container corresponds to an affected batch or batches.

In case it is one of the batches described in the alert, and it is necessary to continue the treatment, you can go to your pharmacy to manage the change of the container by another unaffected.

You can also directly contact the holder of the marketing authorization of the medicine to carry out this management. The information of the holder of the authorization of the medicine is included in the container of the medicine and in the leaflet contained therein.

What Alfuzosin Teva 5 mg is and what it is used for

Alfuzosin Teva 5 mg belongs to a group of medicines called alpha-blockers and is used to treat moderate to severe symptoms caused by an enlarged prostate, a condition also called benign prostatic hyperplasia.

An enlarged prostate can cause urinary problems such as frequent and difficult urination.

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