Class 2 Medicines Recall: Bristol Laboratories Limited, Phenobarbital 60 mg Tablets, EL(22)A/28

Bristol Laboratories Limited are recalling a batch of this product as a precautionary measure due to low dissolution test results reported during ongoing stability studies

MDR Number: MDR 215-01/22

Company name: Bristol Laboratories Limited

Product description: Phenobarbital 60 mg Tablets

Details of the affected batch:

Brief description of problem:

Bristol Laboratories Limited are recalling the above batch of product as a precautionary measure due to low dissolution test results reported during ongoing stability studies.

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:

• This is a precautionary Pharmacy and Wholesaler level recall, therefore no further action is required by patients.
• Patients should continue taking medicines from this batch, as stopping phenobarbital treatment abruptly is likely to cause harm.
• Never stop taking medicines such as phenobarbital without medical advice. Suddenly stopping an epilepsy medicine may cause your seizures to start again or happen more often or last longer than before.
• The Marketing Authorisation Holder have not received any reports of adverse reactions related to the issue above, however, patients who experience a change of their condition or symptoms or any adverse reactions should seek medical attention. These should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For more information, medical or supply enquiries, please contact notifications@bristol-labs.co.uk.

To access the full recall: Class 2 Medicines Recall: Bristol Laboratories Limited, Phenobarbital 60 mg Tablets, EL(22)A/28