Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various Products, EL(25)A/24

Zentiva Pharma UK Limited has informed the MHRA of an issue related to batches of various soluble or effervescent tablets.

DMRC Number: DMRC-35524103

Company name: Zentiva Pharma UK Limited

Product descriptions: 

• Zentiva Paracetamol Soluble Tablets: PL 17780/0198, SNOMED code: 1857611000001102, GTIN: 24 pack: 5000283601807
• Zentiva Paracetamol Soluble Tablets: PL 17780/0162, SNOMED code: 1858211000001100, GTIN: 100 pack: 5000283598565
• Zentiva Co-Codamol 8/500 Effervescent Tablets: PL 17780/0072, SNOMED code: 10517611000001104, GTIN: 32 pack:5000283652038
• Zentiva Co-Codamol 8/500 Effervescent Tablets: PL 17780/0511, SNOMED code: 1914311000001104, GTIN: 100 pack: 5000283588481
• Zentiva Co-Codamol 30/500 Effervescent Tablets: PL 17780/0046, SNOMED code: 5468711000001106, GTIN: 100 pack: 5000283609094

Details of the affected batches: See Full Recall Document for batch numbers

Brief description of problem:

Zentiva Pharma UK Limited has informed the MHRA that the batches of soluble or effervescent tablets listed in the annexes are taking longer than expected to fully dissolve, resulting in an increase in residual material being observed. Additionally, some tablets may appear as having a rough surface on one side identified during further analysis. Following an investigation at the manufacturing site it is confirmed that the safety and efficacy of the tablets is not affected by these issues.

The batches listed as ‘not yet distributed’ may also exhibit the same behaviour and take longer than expected to full dissolve. The MHRA, in discussion with Zentiva Pharma UK Limited, considers that there is no patient safety, quality or efficacy risk due to this issue, therefore these are included in the notification and the expected distribution dates for these batches will take place from 02 June 2025. These products are fast moving and the batches listed in this notification are expected to be consumed within 6 months.

Advice to Healthcare Professionals:

Healthcare professionals are advised to review the information contained within this notification and when medicines from the batches included in the tables are supplied or dispensed, please ensure that patients are aware of the following information:

• Tell the patient that there may be an increased length of time required for the tablets to dissolve (approximately 5 minutes);
• The tablets should be dissolved in a full glass of water (approximately 200 ml) and stirred before drinking;
• If after drinking there are residual particles left in the glass, then they should add more water (approximately 100 ml) and stir before drinking;
• The effectiveness of the tablets is not affected by this longer dissolving time;
• Tell the patient that some tablets may appear to have a slightly rough or uneven surface on one side, but this does not affect the effectiveness of the tablet.

Advice to Patients:

Continue to take tablets from these batches as prescribed by your healthcare professional. The effectiveness of the tablets is not affected by this longer dissolving time. To ensure that you get your complete dose:

• Dissolve the tablets in a glass of water (approximately 200ml), allow the tablets to dissolve (approximately 5 minutes) and stir before drinking;
• If after drinking there are residual particles left in the glass, then add more water (approximately 100 ml) and stir before drinking.

Some tablets may appear to have a slightly rough or uneven surface on one side which does not affect the effectiveness of the tablet. If you notice a significant change in the tablet appearance or have any other concerns, please contact your pharmacist.

Patients who experience adverse reactions or have any questions about their 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 all medical information enquiries and information on this product, please email Zentiva medical information via webform, email UKmedinfo@zentiva.com or telephone 0800 090 2408.

For stock control enquiries please email ukcustomerservices@zentiva.com or telephone 08448 793188.

To access the full recall: Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various Products, EL(25)A/24