Medicines recallMHRA
Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various Products recalled over a quality concern
Zentiva Pharma UK Limited has informed the MHRA of an issue related to batches of various soluble or effervescent tablets.
Check your product
Only products that match these details are covered. Have your pack in front of you.
5 identifiers listed for this notice.
Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various Products
- Product licenceThe PL number on the carton.
- PL 17780/0198
- PL 17780/0162
- PL 17780/0072
- PL 17780/0511
- PL 17780/0046
What to do now
Affected batches of Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various are subject to a recall or defect notice.
- Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
- Compare the batch number printed on the box or label with the batches listed here.
- If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
- Any side effect you think is linked can be reported through the Yellow Card scheme.
Why it matters. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.
If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/24). Quoted as issued.
Summary
Zentiva Pharma UK Limited has informed the MHRA of an issue related to batches of various soluble or effervescent tablets.
The risk
DMRC reference number DMRC-35524103 Marketing Authorisation Holder
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.
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 .
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 .
Open the MHRA notice
Questions
Why has Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various been recalled?
Affected batches of Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various are subject to a recall or defect notice. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.
How do I know if my medicine is affected?
Compare the product licence on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.
Do I need a new prescription?
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.