Tuesday, September 28

Health orders the withdrawal of several batches of omeprazole due to the risk of impurities in the bottle

A new alert from the Spanish Agency for Medicines and Health Products (Aemps) dated August 17, has caused the Ministry of Health, on whom this body depends, has ordered the recall of two lots of Omeprazole Teva due to a defect in the reservoir closure, which can cause the entry of impurities.

Specific, the affected lots are 16738 for Omeprazole Teva Group 40mg and 16873 for Omeprazole Teva-Rimafar 20mg, both with an expiration date of June 30, 2022. The two drugs are presented in containers of gastro-resistant capsules of 56 units.

The Aemps has warned that the failure would be in the “possible release of silica gel granules into the bottles due to a defect in the closure of the reservoir of this desiccant”.

Omeprazole belongs to a group of medicines called proton pump inhibitors. These drugs work by reducing the amount of acid produced by the stomach and are used for ulcers and gastroesophageal reflux diseases.

The agency has classified the defect as class 2. The quality defects of the drugs are classified by the Aemps into three classes (1, 2 and 3), class 1 being the one with the highest possible risk and class 3 the one with the lowest risk.

After observing this defect, the Aemps has ordered the withdrawal from the market of all the distributed units of the affected lots and their return to the laboratory through the usual channels.

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