The Spanish Agency for Health Alerts and Emergencies (AEMPS) has notified the withdrawal of a batch of Omeprazol Altan of 40 milligrams in powder form and a batch of 50 vials for hospital use. The drug is used to treat heartburn. In a statement, the agency said that the affected batch corresponds to the number 22CO169, with an expiry date of 31 March 2023 and which is manufactured and marketed by Altan Pharmaceuticals SA.
AEMPS warns of the detection of an "out-of-specification result in the test for unknown impurities”. In view of this finding, the agency is calling for "the withdrawal from the market of all units distributed of the affected batches and their return to the laboratory through the usual channels". The autonomous regions will be responsible for monitoring this measure.
Omeprazol is one of the most commonly used drugs to alleviate stomach pain. This medicine, used as a protector, is used to deal with the discomfort caused by gastro-oesophageal reflux and uncomfortable heartburn. Its use allows the oesophageal mucosa to heal and prevents possible injury, which can cause a painful burning sensation in the chest and throat and a sour taste in the mouth.