Health alert: Health withdraws a batch of a well-known omeprazole from pharmacies
New health alert. The Spanish Medicines Agency (AEMPS) has issued a notice linked this time to a popular drug to combat heartburn. The warning in question affects Omeprazole Stada 40 mg gastro-resistant hard capsules, due to an “out-of-specification result in the content of active ingredient.” The medicine, with registration number 69487 and national code 660281, is sold in a presentation of 28 capsules in a blister. The batch that caused the alert is LC63278 with an expiration date of July 31, 2024.
The holder of the marketing authorization is the Stada, SL laboratory and the manufacturer is the Liconsa, SA laboratory. The defect detected by the AEMPS is classified as class 3. As a precautionary measure, the withdrawal from the market of all distributed units has been ordered. of the affected batch and its return to the laboratory through the usual channels. The autonomous communities must now monitor their withdrawal and ensure that the measures adopted are complied with.
Over-the-counter omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days per week) in adults. This drug belongs to a class of medications called proton pump inhibitors. Its action is to reduce the amount of acid produced in the stomach. According to its label, it is used to treat the following diseases:
– ‘Gastroesophageal reflux disease’ (GERD). In this disorder, stomach acid passes into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and burning.
-Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
– Ulcers infected by a bacteria called ‘Helicobacter pylori’.
– Ulcers caused by medications called NSAIDs (non-steroidal anti-inflammatory drugs).
– Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).