Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various Products, EL(25)A/24
Source: gov.uk (2025-06-02)

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

DMRC reference number

DMRC-35524103

Marketing Authorisation Holder

Zentiva Pharma UK Limited

Medicine Details

Zentiva Paracetamol Soluble Tablets

PL 17780/0198

Active Ingredient: Paracetamol

SNOMED code: 1857611000001102

GTIN: 24 pack: 5000283601807

FOR AFFECTED LOT/BATCH NUMBERS – SEE ANNEX 1 (https://assets.publishing.service.gov.uk/media/683883a3e0f10eed80aafb17/EL_25_A24_Final_RC_v3.pdf#page=4)

Zentiva Paracetamol Soluble Tablets

PL 17780/0162

Active Ingredient: Paracetamol

SNOMED code: 1858211000001100

GTIN: 100 pack: 5000283598565

FOR AFFECTED LOT/BATCH NUMBERS – SEE ANNEX 1 (https://assets.publishing.service.gov.uk/media/683883a3e0f10eed80aafb17/EL_25_A24_Final_RC_v3.pdf#page=4)

Zentiva Co-Codamol 8/500 Effervescent Tablets

PL 17780/0072

Active Ingredient: Paracetamol and codeine phosphate

SNOMED code: 10517611000001104

GTIN: 32 pack:5000283652038

FOR AFFECTED LOT/BATCH NUMBERS – SEE ANNEX 2 (https://assets.publishing.service.gov.uk/media/683883a3e0f10eed80aafb17/EL_25_A24_Final_RC_v3.pdf#page=6)

Zentiva Co-Codamol 8/500 Effervescent Tablets

PL 17780/0511

Active Ingredient: Paracetamol and codeine phosphate

SNOMED code: 1914311000001104

GTIN: 100 pack: 5000283588481

FOR AFFECTED LOT/BATCH NUMBERS – SEE ANNEX 2 (https://assets.publishing.service.gov.uk/media/683883a3e0f10eed80aafb17/EL_25_A24_Final_RC_v3.pdf#page=7)

Zentiva Co-Codamol 30/500 Effervescent Tablets

PL 17780/0046

Active Ingredient: Paracetamol and codeine phosphate

SNOMED code: 5468711000001106

GTIN: 100 pack: 5000283609094

FOR AFFECTED LOT BATCH NUMBERS – SEE ANNEX 3 (https://assets.publishing.service.gov.uk/media/683883a3e0f10eed80aafb17/EL_25_A24_Final_RC_v3.pdf#page=7)

Affected Lot Batch Numbers

See Download Document (https://assets.publishing.service.gov.uk/media/683883a3e0f10eed80aafb17/EL_25_A24_Final_RC_v3.pdf#page=4) for batch numbers

Background

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 for 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 for 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 (https://yellowcard.mhra.gov.uk/).

Additional information:

For all medical information enquiries and information on this product, please email Zentiva medical information via webform (https://www.zentiva.co.uk/contact/mi-form), email xxx@xxx.xx (mailto:xxx@xxx.xx) or telephone xx-xxxx-xxxx.

For stock control enquiries please email xxx@xxx.xx (mailto:xxx@xxx.xx) or telephone xx-xxxx-xxxx.

Recipients of this Medicines Recall 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 Centre10 South ColonnadeCanary WharfLondonE14 4PU

Telephone xx-xxxx-xxxx

xxx@xxx.xx (mailto:xxx@xxx.xx)

Download document

Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various Products, EL(25)A/24 (https://assets.publishing.service.gov.uk/media/683883a3e0f10eed80aafb17/EL_25_A24_Final_RC_v3.pdf)