The Medicines and Healthcare Regulatory Authority (MHRA) has recalled specific batches of Paracetamol 500mg Tablets (Chelonia Healthcare Limited) as a precautionary measure, ‘due to contamination’.
The move follows a small number of complaints of discoloured tablets within some packs, reported by healthcare professionals.
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In a class 2 medicines notification issues today, Chelonia Healthcare Limited has recalled specific batches of Paracetamol 500mg Tablets (100 pots) as a precautionary measure. The batches affected are 2312010 and 2312011 and the reference number is DMRC-35796576
Chelonia Healthcare Limited said the issue has only been identified in batch 2312010, however as a precautionary measure, batch 2312011 is also being recalled to mitigate any risk, as the investigation and analysis remain ongoing.
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The MHRA advises healthcare professionals to stop supplying the affected batches immediately, to quarantine all remaining stock and return it to their supplier.
It advises patients to check to see if they have received tablets from the listed batches of Paracetamol 500 mg Tablets, which can only be obtained from a pharmacy with a prescription and to contact their pharmacy if they find tablets that are discoloured in any way, in pots from the listed batches.
Patients who experience adverse reactions or have any questions about the medication, should seek medical attention.
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Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme. Last week, the MHRA issued advice to pharmacists about batches of soluble or effervescent paracetamol tablets manufactured by Zentiva Pharma UK Limited after the tablets were taking longer than expected to fully dissolve, resulting in an increase in residue.
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