Update – MHRA Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules (Jubilant Pharmaceuticals NV)

This recall notification has been updated since its initial publication on 11 March 2025 to include the correct information in relation to the safety updates in the Patient Information Leaflet (PIL) and the changes that have been made in line with reference product PIL.

MHRA Class 4 Medicines Notification: Azithromycin 250 mg Capsules (Jubilant Pharmaceuticals NV)

Drug alert number: EL(25)A/11

Date issued: 11 March 2025

Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in the table include an outdated PIL. These packs contain a PIL which was revised in October 2021. The latest approved PIL is dated February 2025.

DMRC reference number: DMRC-34866680

Company name: Jubilant Pharmaceuticals NV

Product name: Azithromycin 250 mg Capsules PL 19156/0138

SNOMED Code:1303911000001105 (4 Cap/pack), 1135911000001109 (6 Cap/pack)

Active Pharmaceutical Ingredient: azithromycin dihydrate

Background

Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in the table above include an outdated PIL. These packs contain a PIL which was approved prior to 2021 but should contain a PIL that was updated in October 2021. Subsequently, a new PIL has been approved in February 2025.

The out of date PIL in the tabled batches is missing important updated safety information, please refer to the table in Appendix 2 and a copy of the full PIL is also available on the MHRA website.

Advice for healthcare professionals

Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing this product. When products from batches included in the table is supplied or dispensed, please ensure that patients are aware of the missing information which is summarised in the ‘Advice for Patients’ box below and provided in Appendix 2. As the patients would not find current PIL (dated: February 2025) in the packs, please inform the patients that the latest PIL for Azithromycin Capsules is available on the MHRA website.

View full alert here

Advice for patients

Patients should continue to take medicines from the impacted batches as prescribed by your healthcare professional. This does not affect the quality of the product. There is updated safety information in the latest patient information leaflet (PIL) which accompanies the medicine. The latest PIL is available on the MHRA website. As per current PIL there is some missing information which is presented below:

What you need to know before you take Irbesartan Jubilant – Other medicines and Azithromycin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines

• Hydroxychloroquine or chloroquine (used to treat conditions including rheumatoid arthritis, or to treat or prevent malaria): Taking these medicines at the same time as azithromycin may increase the chance of you getting side effects that affect your heart.

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.

Additional information:

For medical information enquiries please email safety.uk@lambda-cro.com or telephone 0080089013370

For stock control enquiries please email JPUK.Customerservice@jubl.com , or telephone 01233 552293