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Medicines defect noticeMHRA

Linezolid 600 mg film-coated 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 Linezolid 600 mg film-coated tablets.

Check your product

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

4 identifiers listed for this notice.

  • Linezolid 600 mg film-coated tablets X10

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • NS2637
    Product licenceThe PL number on the carton.
    • PL 04416/1389
    ExpiryOn the carton, blister or label.
    • February 2027
    First distributedOn the product, its label or its packaging.
    • 13 May 2024

What to do now

The issue with Linezolid 600 mg film-coated tablets is information: something on the packaging or leaflet is wrong or missing.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the 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/48). 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 Linezolid 600 mg film-coated tablets.

The risk

DMRC reference number DMRC 31944581 Company name

Advice for healthcare professionals

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

The missing information from the SmPC is already covered under other sections:

The missed extension of thrombocytopenia to patients with hepatic impairment under section 4.4 of the SmPC is already included in same section under sub section special population where it is recommended that linezolid should be given to patients with severe hepatic insufficiency only when the perceived benefit outweighs the theoretical risk. Hyponatremia and/ (SIADH) is already listed twice under section 4.8 of the SmPC under metabolism disorders & investigations

The missed ADR of Hypersensitivity vasculitis missing under section 4.8 of the SmPC SOC skin & subcutaneous tissue disorders is covered under broader topic as a contraindication in section 4.3

The missed warning under section 4.4 of the SmPC on Impairment of fertility is limited to adult male rats and already covered under section 4.6 of the SmPC “Fertility, pregnancy & lactation”.

The missed frequency upgrade in section 4.8. are considered of minor impact for patient safety. All ADRs for which frequency has been updated are already listed in the SmPC.

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

If the medicine listed in this notification is supplied or dispensed, ensure that patients are aware of the information missing from the PIL on warnings prior to taking Linezolid and possible side-effects (see Annex 1, Table 2 ). It is important to advise patients that if they experience any of the symptoms listed in Table 2, they should seek immediate medical advice.

Sandoz Ltd has confirmed that all future batches of the product will contain the updated PIL

Patients do not need to take any action. The information in Annex 1, Table 2 is missing from the Patient Information Leaflet. The missing information does not change or affect the quality of the product. Therefore, you can safely continue your treatment. However, should you experience any reactions or symptoms matched with the information in Table 2, or you have a history of hyponatraemia, or you take medicines that lower blood sodium levels, please urgently 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 1, Table 2 is missing from the Patient Information Leaflet. The missing information does not change or affect the quality of the product. Therefore, you can safely continue your treatment. However, should you experience any reactions or symptoms matched with the information in Table 2, or you have a history of hyponatraemia, or you take medicines that lower blood sodium levels, please urgently 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 Linezolid 600 mg film-coated tablets been recalled?

The issue with Linezolid 600 mg 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?

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.

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