Safety Report: Labetalol 200mg Tablets - recalled due to an error on the foil blister packaging, UK

United Kingdom

Tillomed Laboratories Limited 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. The description on the carton of a strength of ‘Labetalol 200mg Tablets’ is correct.

The recalled product is
Labetalol 200mg Tablets, PL 11311/0376
Pack size: 56 (4x14)
SNOMED Code: 36537111000001109.
Batch number: 221345
Expiry date: 08/2025
First distributed: 15/05/2023
Active Pharmaceutical Ingredient: Labetalol hydrochloride

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.

Advice for patients

If you were prescribed Labetalol 200mg and have a pack that contains a blister that states Labetalol 100mg Tablet on the foil blister (which matches with batch/lot number 221345 and expiry date of 08/2025), the tablets inside will be Labetalol 200mg Tablets as per your prescription. You can check the tablet, which should match the description as detailed in the Patient Information Leaflet. The Labetalol 200mg Tablet is “Orange, round biconvex film-coated tablet coded LTL 200” on one side.

If you have an incorrectly labelled blister as mentioned in this notification or you have any concerns, please contact your pharmacist directly who can advise and arrange for a replacement. If the prescription was written within 6 months, the pharmacist will arrange for the dispensing of a pack that does not contain the incorrect blister foil labelling, otherwise you may need to seek advice from your GP for a further prescription.

If you have accidentally taken too many tablets, please seek immediate medical advice. Remember to take the leaflet that came with your medicine and any remaining tablets with you, Symptoms of overdose include low blood pressure (hypotension), slower heartbeat (bradycardia), difficulty in breathing or wheezing (bronchospasm), drowsiness, confusion, seizures, hallucinations, and dilated pupils.

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your 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 Limited 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.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: www.gov.uk/drug-device-alerts/class-2-medicines-recall-tillomed-laboratories-limited-labetalol-200mg-tablets-el-23-a-slash-23