Glenmark Pharmaceuticals Europe is recalling one batch of Omeprazole 20 mg/15 ml oral solution as a precautionary measure following a customer complaint indicating ‘precipitation and discoloration’ of the product in the bottles.
The recall specifically affects batch number 3230528 (expiry date: 30/09/2025), distributed in packs of 14 bottles. The batch of medication, used to treat heartburn and indigestion, was first distributed on 29 January 2024.
An alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said the issue was ‘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’.
Pharmacists are advised to immediately cease supplying the affected batch, quarantine remaining stocks, and return them via approved supplier processes.
The MHRA said that as this was a pharmacy and wholesaler level recall, ‘no further action is required by patients’.
‘Patients should continue to take medicines from these batches as prescribed by your healthcare professional,’ it added.
Patients who experience adverse reactions or have any questions about the medication have been advised by the MHRA to seek medical attention.
Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
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