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MHRA recalls Labetalol 200mg tablets

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The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled Labetalol 200mg tablets (Tillomed Laboratories Ltd) directed to pharmacies and wholesalers.

Manufacturer, Tillomed Laboratories is recalling one batch of Labetalol 200mg tablets due to an error on the foil blister packaging.

The incorrect aluminium foil blister packaging states Labetalol 100mg tablets, however it should be labelled as Labetalol 200mg Tablets. This error has occurred at the primary packing operation.

Tillomed Laboratories Limited has confirmed the actual tablet contained in the blister is Labetalol 200mg Tablets, which is the strength stated on the outer carton. This error is limited to the packaging of the batch with 100mg aluminium foil blister and does not impact the lot (batch) number or expiry as printed on the outer carton and aluminium foil blister.

Healthcare professionals has been advised to stop supplying the batches immediately. Quarantine all remaining stock and return it to supplier using supplier’s approved process.

This recall is at pharmacy and wholesaler level and not directed to patient level. However, patients may present with the incorrectly labelled aluminium foil blister.

Pharmacy teams should exercise their professional judgement to supply the correct pack, however there is no impact to the overall tablet, as Tillomed Laboratories have confirmed that all blisters for this batch contain the 200mg strength tablets. If the prescription was written within 6 months, pharmacists can arrange for the dispensing of a pack that does not contain the incorrect blister foil labelling.

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