Medicine recalls
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| The United Kingdom: Class 3 Medicines Recall: Omeprazole 20 mg/15 ml Oral Solution, Glenmark Pharmaceuticals Europe Ltd |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole 20 mg/15 ml Oral Solution (batch number: 3230528) as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration 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.
Omeprazole is used in conditions where inhibition of gastric acid secretion may be beneficial, including aspiration syndromes, dyspepsia, gastro-oesophageal reflux disease, peptic ulcer disease and the Zollinger-Ellison syndrome.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-omeprazole-20-mg-slash-15-ml-oral-solution-glenmark-pharmaceuticals-europe-ltd-el-25-a-slash-30
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Jul 2, 2025
Issued at HKT 18:00
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