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Medicines defect noticeMHRA

Rosuvastatin 20mg, 40mg Tablets defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Rosuvastatin 20mg and 40mg Tablets.

Check your product

Only products that match these details are covered. Have your pack in front of you.

20 identifiers listed for this notice.

  • Rosuvastatin 20mg, 40mg Tablets 28

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • NL8148
    • NW1590
    • NW1591
    • NJ2462
    • NU8004
    • NX2653
    • NU8003
    Product licenceThe PL number on the carton.
    • PL 04416/1425
    • PL 04416/1426
    ExpiryOn the carton, blister or label.
    • Sep 2025
    • Apr-2026
    • Apr 2026
    • Aug 2025
    • Feb 2026
    • Mar 2026
    First distributedOn the product, its label or its packaging.
    • 18/01/2024
    • Not yet distributed
    • 15/11/2023
    • 13/06/2024
    • 16/08/2024

What to do now

There is an error on the label, carton or patient leaflet for Rosuvastatin 20mg, 40mg Tablets.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. 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

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.

Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/45). Quoted as issued.

Summary

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Rosuvastatin 20mg and 40mg Tablets.

The risk

DMRC reference number DMRC 32407021 Company name

Advice for healthcare professionals

There is no risk to product quality or impact to safety of the medicines listed in this notification because of this missing information, full details in Annex – Table 1 .

The information missing in Sections 4.1 and 4.2 of the SmPC pertains to the use of rosuvastatin in children aged 6 years with Homozygous familial hypercholesterolaemia, which is an approved condition. The reference SmPC has updates to include additional details about this approved use.

The updated text in the lactation section now includes information that rosuvastatin is found in breast milk and may be harmful to infants. This aligns with the current Sandoz SmPC, which already advise against using rosuvastatin during pregnancy and lactation in Sections 4.6 and 4.3. The information on fertility was already present but has now been separated into its own heading to comply with changes in the SmPC template.

The updated text regarding fusidic acid clarifies that there have been no studies conducted on the interaction between rosuvastatin and fusidic acid. However, the interaction was already described in the Sandoz SmPC in Section 4.5 “Interaction with other medicinal products and other forms of interaction”.

The updated information in the reference SmPC from clinical trials shows that roxadustat, teriflunomide, capmatinib, fostamatinib, febuxostat, and tafamidis can increase rosuvastatin area under the curve (AUC) levels by 1.9 to 2.9 times. However, the current Sandoz SmPC already states in Section 5.2 and 4.5 that the “elimination half-life of rosuvastatin does not increase with higher doses, and caution should be taken if the rosuvastatin dose exceeds 20 mg.”

The PIL is missing information related to telling your doctor if you are taking any of the following medication: roxadustat, teriflunomide, capmatinib, fostamatinib, febuxostat, and tafamidis.

Considering the above omissions, the majority of the safety information is already covered in other sections of the Sandoz SmPC and PIL.

Healthcare professionals are advised to review the content of this notification, as it provides information that is missing from the current SmPC and PIL on the existing clinical concepts (as detailed above) and take this into account when prescribing.

If the medicines listed in this notification are supplied or dispensed, ensure that patients are aware of the information missing from the PIL on interaction with other medicines see table 2 of Annex 1 . Advise patients that if they are taking any of the medications listed in table 2 of Annex 1 they should discuss this with their prescribing healthcare professional before they start taking the medication.

Due to supply considerations, batches listed as not yet distributed will not be repackaged with the updated PIL prior to distribution. The specified ‘Not yet distributed’ batches are scheduled to be distributed shortly to avoid any supply considerations. Sandoz Ltd. has confirmed that all future batches (not listed in this notification) of the product will contain the updated PIL.

Patients do not need to take any action. The information in Annex – Table 2 is missing from the Patient Information Leaflet. The missing information, summarised in this notification, does not change or affect the quality of the product. Therefore, you can safely continue your treatment. However, should you experience any adverse effects/side effects with the prescribed medication please contact your healthcare professional.

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

Patients do not need to take any action. The information in Annex – Table 2 is missing from the Patient Information Leaflet. The missing information, summarised in this notification, does not change or affect the quality of the product. Therefore, you can safely continue your treatment. However, should you experience any adverse effects/side effects with the prescribed medication please contact your healthcare professional.

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 Rosuvastatin 20mg, 40mg Tablets been recalled?

There is an error on the label, carton or patient leaflet for Rosuvastatin 20mg, 40mg Tablets. 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?

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

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