Medicines defect noticeMHRA
Paracetamol 500mg, 1000mg Film-Coated Tablets defect notice over a labelling error
Dawa Limited has informed the MHRA that specified batches listed in this notification have been packed with an outdated Patient Information Leaflet (PIL).
Check your product
Only products that match these details are covered. Have your pack in front of you.
10 identifiers listed for this notice.
Product 1 32
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 220103
- 220105
- Product licenceThe PL number on the carton.
- PL 30684/0232
- PL 30684/0233
- ExpiryOn the carton, blister or label.
- 02/2025
- First distributedOn the product, its label or its packaging.
- 19/12/2023
- 20/10/2023
Product 2 100
- Batch code
- 220106
- Expiry
- 02/2025
- First distributed
- 30/10/2023
What to do now
The issue with Paracetamol 500mg, 1000mg Film-Coated Tablets is information: something on the packaging or leaflet is wrong or missing.
- Keep taking your medicine unless a healthcare professional tells you otherwise.
- Check the batch number and expiry date on your pack against the list on this page.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
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(24)A/21). Quoted as issued.
Summary
Dawa Limited has informed the MHRA that specified batches listed in this notification have been packed with an outdated Patient Information Leaflet (PIL).
The risk
MDR number MDR 312-04/24 Company name
Advice for healthcare professionals
There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL. The updated leaflet can be accessed via the following links:
Paracetamol 500mg Film-Coated Tablets
Paracetamol 1000mg Film-Coated Tablets
Alternatively, printed copies of the PIL can be requested from Drugsrus Limited (distributor) so that any remaining stock in the dispensary can be supplemented with the correct PIL (see contact details under “Further information” ).
The Marketing Authorisation Holder has confirmed that undistributed packs of these batches will be repacked with the correct version of the PIL. These packs are identifiable by tamper-evident seals that indicate packs with the updated leaflet.
The medicine itself is not affected and patients do not need to take any action. Patients should continue to take medicines from these batches as prescribed by your healthcare professional. If you are taking flucloxacillin and have any concerns, please talk to your doctor or pharmacist.
Patients should be aware that the Patient Information Leaflet (PIL) that accompanies the above named batches of Paracetamol 500mg and 1000mg Film-Coated Tablets is missing information in Section 2. The missing information can be found in the background section above.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme .
Advice for patients
The medicine itself is not affected and patients do not need to take any action. Patients should continue to take medicines from these batches as prescribed by your healthcare professional. If you are taking flucloxacillin and have any concerns, please talk to your doctor or pharmacist.
Patients should be aware that the Patient Information Leaflet (PIL) that accompanies the above named batches of Paracetamol 500mg and 1000mg Film-Coated Tablets is missing information in Section 2. The missing information can be found in the background section above.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme .
Open the MHRA notice
Questions
Why has Paracetamol 500mg, 1000mg Film-Coated Tablets been recalled?
The issue with Paracetamol 500mg, 1000mg Film-Coated Tablets is information: something on the packaging or leaflet is wrong or missing. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
How do I know if my medicine is affected?
Compare the batch code, product licence, expiry and date code 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?
Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.
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.