Class 4 Medicines Defect Information: Max Remedies Ltd, Max Healthcare Paracetamol 500 mg Capsules, EL (23)A/37

Max Remedies has identified an infrequent printing error relating to the Braille text printed on the cartons of various batches of this product.

MDR Number: MDR 191-09/23

Company name: Max Remedies Ltd

Product description: Max Healthcare Paracetamol 500 mg Capsules, PL 31308/0004

Details of the affected batches:

Brief description of problem:

Max Remedies has identified an infrequent printing error relating to the Braille text printed on the cartons. Some characters may be incorrect leading to potential misinterpretation of the contents/strength of the product. Specific examples of the types of error reported can be found in the full recall (link below)

Advice to Healthcare Professionals:

We would advise that blind and/or partially sighted patients are instructed to follow the directions outlined in the PIL as normal and if there are concerns, they should consult with their carer, or alternatively contact Max Remedies. The quality of the capsules is not impacted by this defect and all written information on the packs is correct.

Advice to Patients:

Blind and/or partially sighted patients are advised that these are paracetamol 500 mg tablets and should be taken as directed in the PIL. If there are concerns, consult with your carer, or alternatively contact Max Remedies. The quality of the capsules is not impacted by this defect.

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 or stock control enquiries please email Gary.Elliott@ivcbrunel.co.uk or telephone 07720740832

To access the full recall: Class 4 Medicines Defect Information: Max Remedies Ltd, Max Healthcare Paracetamol 500 mg Capsules, EL (23)A/37