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

Medicines Healthcare Products Regulatory Agency

September 27
12:58 2023

MDR number

MDR 191-09/23

Company name

Max Remedies Ltd

Product name

Max Healthcare Paracetamol 500 mg Capsules, PL 31308/0004

Batch No Expiry Date Pack Size First Distributed
EG22PAA040 Nov 2025 16 Capsule Pack March 2023
EG22PAA041 Nov 2025 16 Capsule Pack March 2023
EG23PAA001 Dec 2025 16 Capsule Pack May 2023
EG23PAA002 Dec 2025 16 Capsule Pack May 2023
EG23PAA003 Dec 2025 16 Capsule Pack May 2023
EG23PAA004 Dec 2025 16 Capsule Pack May 2023
EG23PAA005 Dec 2025 16 Capsule Pack May 2023
EG23PAA006 Dec 2025 16 Capsule Pack May 2023
EG23PAA010 Feb 2026 16 Capsule Pack June 2023
EG23PAA011 Feb 2026 16 Capsule Pack June 2023
EG23PAA012 Feb 2026 16 Capsule Pack June 2023
EG23PAA013 Feb 2026 16 Capsule Pack June 2023
EG23PAA014 Feb 2026 16 Capsule Pack June 2023
EG23PAA015 Feb 2026 16 Capsule Pack July 2023
EG23PAA016 April 2026 16 Capsule Pack July 2023
EG23PAA017 April 2026 16 Capsule Pack July 2023
EG23PAA018 April 2026 16 Capsule Pack July 2023
EG23PAA019 April 2026 16 Capsule Pack July 2023
EG23PAA020 April 2026 16 Capsule Pack July 2023
EG23PAA021 April 2026 16 Capsule Pack July 2023

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:

Observed Incomplete Braille Potential Misinterpretation
T from PARACETAMOL Read as PARACEJAMOL
L from CAPSULES No equivalent character
U from CAPSULES Read as : or -
P from PARACETAMOL Read as FARACETAMOL
0 from 500 Read as 50:
0 from 500 Read as 50-
U from CAPSULES Read as : or
M from mg No equivalent character
M from mg Read as fg
P from CAPSULES Read as CAFSULES
P from CAPSULES Read as CA/SULES

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

Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU

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

Published 27 September 2023

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