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Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited recalled over a packaging defect

Packaging or device defectHigh riskClass 2

Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error on one side of the carton.

Check your product

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

7 identifiers listed for this notice.

  • Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited 10

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 0191Y
    • AG07093D
    • 9982X
    • AG11871C
    ExpiryOn the carton, blister or label.
    • 31/05/2026
    • 31/03/2026
    First distributedOn the product, its label or its packaging.
    • 16/04/2025

What to do now

Some packs of Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited have a defect that could affect how the medicine is given.

  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. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

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

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.

An affected pack bought over the counter can be returned to where you bought it.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/27). Quoted as issued.

Summary

Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error on one side of the carton.

The risk

DMRC reference number DMRC-35838791 Marketing Authorisation Holder

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.

Maxearn have informed the MHRA that approximately 14 defective packs (each containing 10 prefilled syringes) have been released to pharmacies. All other units from these batches have been held before onward distribution. Maxearn will arrange for customers to be contacted, including pharmacies, that have received the defective packs.

Pharmacists who have been supplied this batch and suspect they have dispensed the medicine to patients should contact the patient immediately to make them aware of this error. Please see ‘advice for patients’ section below.

Patients who have been prescribed Inhixa 2,000 IU (20mg)/0.2 mL should check the batch number of their pre-filled syringes, (printed on the foil of the individual prefilled syringe label or on the carton). Patients who have received batches 0191Y / AG07093D or 9982X / AG11871C, should contact their pharmacist or GP immediately.

Patients who have been prescribed 12,000 IU (120mg)/0.8 ml should verify the strength of the medicine by checking the information on the other sides of the carton, PIL included and inner labels on the actual syringe. Continue to take the medicine as prescribed by your doctor.

Do not stop taking your medicine without consulting your healthcare provider. Patients who are concerned about the strength of the medication they have received should check it with their dispensing pharmacy.

Patients who are concerned they may have taken an incorrect dose of the medication than what should have been prescribed should seek medical attention.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Advice for patients

Patients who have been prescribed Inhixa 2,000 IU (20mg)/0.2 mL should check the batch number of their pre-filled syringes, (printed on the foil of the individual prefilled syringe label or on the carton). Patients who have received batches 0191Y / AG07093D or 9982X / AG11871C, should contact their pharmacist or GP immediately.

Patients who have been prescribed 12,000 IU (120mg)/0.8 ml should verify the strength of the medicine by checking the information on the other sides of the carton, PIL included and inner labels on the actual syringe. Continue to take the medicine as prescribed by your doctor.

Do not stop taking your medicine without consulting your healthcare provider. Patients who are concerned about the strength of the medication they have received should check it with their dispensing pharmacy.

Patients who are concerned they may have taken an incorrect dose of the medication than what should have been prescribed should seek medical attention.

Patients who experience adverse reactions or have any questions about the 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 Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited been recalled?

Some packs of Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited have a defect that could affect how the medicine is given. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

How do I know if my medicine is affected?

Compare the batch code, 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?

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.

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