The Spanish Medicines Agency (AEMPS) has issued an alert linked to a popular drug used to combat heartburn. The warning relates to Omeprazole Stada 40mg hard gastroresistant capsules, due to an "out-of-specification result in the active ingredient content".
The medicine, with registration number 69487 and national code 660281, is sold in a blister pack of 28 capsules. The batch that triggered the alert is LC63278 with an expiry date of 31 July 2024.
The marketing authorisation holder is the laboratory Stada, S.L. and the manufacturer is the laboratory Liconsa, S.A. The defect detected by the AEMPS is classified as class 3. As a precautionary measure, all units of the affected batch have been ordered to be withdrawn from the market and returned to the laboratory through the usual channels. The Spanish regions must now monitor the 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 two or more days per week) in adults. It belongs to a class of drugs called proton pump inhibitors. It works by decreasing the amount of acid produced in the stomach.