GovWire

MDR number

MDR 191-09/23

Company name

Max Remedies Ltd

Product name

Max Healthcare Paracetamol 500 mg Capsules, PL 31308/0004

Active Pharmaceutical Ingredient: Paracetamol

Brief description of the 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 include:

Advice for healthcare professionals and retailers

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 for 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.

Further Information

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

Recipients of this notice should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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