Medicines recallMHRA
Fluenz Tetra nasal spray suspension recalled over a labelling error
AstraZeneca UK Ltd. has informed the MHRA of an issue related to the expiry dates for certain batches of Fluenz Tetra. This recall provides further advice on the safe use of the product up to the amended expiry date.
Check your product
Only products that match these details are covered. Have your pack in front of you.
18 identifiers listed for this notice.
Fluenz Tetra nasal spray suspension 10 sprayers
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- TH2127
- TH2127B
- TH3110
- TH3110B
- TJ2290B
- TJ2290
- ExpiryOn the carton, blister or label.
- 28-Dec-23
- 23-Dec-23
- 01-Jan-24
- 02-Jan-24
- 29-Dec-23
- 10-Jan-24
- 05-Jan-24
- 11-Jan-24
- 06-Jan-24
- First distributedOn the product, its label or its packaging.
- 30-Aug-23
- 01-Sep-23
- 11-Sep-23
What to do now
A printing or labelling mistake affects some packs of Fluenz Tetra nasal spray suspension.
- 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
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(23)A/39). Quoted as issued.
Summary
AstraZeneca UK Ltd. has informed the MHRA of an issue related to the expiry dates for certain batches of Fluenz Tetra. This recall provides further advice on the safe use of the product up to the amended expiry date.
The risk
MDR number MDR 298-09/23 Company name
Advice for healthcare professionals
The advice for healthcare professionals includes specific actions on continuing to use the vaccines up until the amended expiry date. Disseminate this information within 5 days, ensure any of the above batches are identified and used within the amended expiry date. After the amended expiry date, any unused products should be quarantined for return. This timeframe relates to acknowledging the information contained within the alert and ensuring that no vaccines are administered after the amended expiry date .
Healthcare professionals, specifically those involved in the administration of this vaccine should continue to use the vaccine as directed. The vaccines may be administered safely up to the amended expiry date . Batches administered before the amended expiry date are fully effective.
Except for the amended expiry date, there are no other changes to the product information.
Any stock that has not been administered before the amended expiry date should be quarantined. All quarantined stock should be returned to your supplier using your supplier’s approved process. For stock return enquiries, please contact Movianto Customer Care on 01234 587207 or Moviantouk.NHSCC@movianto.com ; For stock return enquiries in Northern Ireland, please email contact.nireland@movianto.com .
No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Fluenz Tetra is administered under the supervision of a healthcare professional. Healthcare professionals will ensure that these batches are not used after the amended expiry date; if there is any concern, discuss this alert with the administering healthcare professional. The products may be safely administered up to the amended expiry date. In the unlikely event that you receive the vaccination after the amended expiry date, it should not cause harm, but it may be less effective against one of the four strains of flu included in the vaccine.
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
No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Fluenz Tetra is administered under the supervision of a healthcare professional. Healthcare professionals will ensure that these batches are not used after the amended expiry date; if there is any concern, discuss this alert with the administering healthcare professional. The products may be safely administered up to the amended expiry date. In the unlikely event that you receive the vaccination after the amended expiry date, it should not cause harm, but it may be less effective against one of the four strains of flu included in the vaccine.
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 Fluenz Tetra nasal spray suspension been recalled?
A printing or labelling mistake affects some packs of Fluenz Tetra nasal spray suspension. 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, 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.