A batch of Omeprazole, a medication commonly used to treat conditions such as indigestion, has been recalled following a complaint. The Medicines and Healthcare products Regulatory Agency (MHRA) announced the recall on Monday.
Omeprazole is widely used to treat indigestion, heartburn and acid reflux, according to the NHS. It also serves to prevent and treat stomach ulcers.
The NHS explained: “Omeprazole is a type of medicine called a proton pump inhibitor (PPI). Proton pumps are enzymes in the lining of your stomach that help it make acid to digest food. Omeprazole prevents proton pumps working properly, which reduces the amount of acid the stomach makes.”
In some cases, Omeprazole is taken for a rare condition caused by a tumour in the pancreas or gut known as Zollinger-Ellison syndrome. It comes in various forms, including capsules, tablets and liquid.
The recalled batch pertains to the liquid form of the medication.
The MHRA said: “Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discolouration of the product in the bottles. A root cause has identified that this is a result of an inadequate assembly of the plunger stem and the cup, which could lead to a premature mixing of the two components of the medicinal product.”
Healthcare workers have been ordered to halt the distribution of an impacted batch of medication. They must immediately sequester any residual stock and send it back to their distributor.
The MHRA has assured that no extra steps are needed from patients, adding: “Patients should continue to take medicines from these batches as prescribed by your healthcare professional.
“Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.”