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 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 Capsules 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
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