Class 2 Medicines Recall: Bristol Laboratories Ltd, Phenobarbital Bristol Labs 15mg Tablets, EL(24)A/50

Bristol Laboratories Ltd. are recalling one batch of Phenobarbital Bristol Labs 15mg Tablets as a precautionary measure due to the potential of contamination of small metallic particles within the tablets.

DMRC/MDR Number: DMRC-32910584

Company name: Bristol Laboratories Ltd

Product description: Phenobarbital Bristol Labs 15mg Tablets, PL 17907/0175 SNOMED Code 21039211000001106

Details of the affected batch: 

Brief description of problem:

Bristol Laboratories Ltd. are recalling one batch of Phenobarbital Bristol Labs 15mg Tablets as a precautionary measure due to the potential of contamination of small metallic particles within the tablets.

Bristol Laboratories have received one single market complaint relating to a tablet which had been cut in half by the patient prior to administration, revealing the small metallic particle within the tablet core. There have been no other similar reports related to this batch, since the batch was first distributed in December 2022. Whilst preliminary investigations indicate that this contamination is not widespread further investigations are necessary and ongoing. Bristol Laboratories consider it necessary however, to conduct a precautionary recall of the batch whilst such investigations are ongoing.

Advice to Healthcare Professionals:

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Advice to Patients:

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Never stop taking medicines such as phenobarbital without medical advice, especially if they are being used for epilepsy. Suddenly stopping an epilepsy medicine may cause your seizures to start again or happen more often or last longer than before.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For medical information enquiries please contact: Notifications@bristol-labs.co.uk

For stock control enquiries please contact: Notifications@bristol-labs.co.uk

To access the full recall: Class 2 Medicines Recall: Bristol Laboratories Ltd, Phenobarbital Bristol Labs 15mg Tablets, EL(24)A/50