UPDATE: Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11
Source: gov.uk (2025-03-12)

Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed is outdated.

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.

DMRC reference number

DMRC-34866680

Marketing Authorisation Holder

Jubilant Pharmaceuticals NV

Medicine Details

Azithromycin 250 mg Capsules

Licence: PL 19156/0138

Active ingredient: azithromycin dihydrate

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

GTIN: See Table in Appendix 1 of the download document (#attachment)

Affected Lot Batch Numbers

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the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in the table above include an outdated PIL.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The out of date PIL in the tabled batches is missing important updated safety information, please refer to the table in Appendix 2 (#attachment) and a copy of the full PIL is also available on the MHRA website. (https://mhraproducts4853.blob.core.windows.net/docs/f4fbb641c2af3d149295bdea155138b03c7cf56c)

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 are 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 (#attachment). As the patients would not find the correct PIL in the packs. Please inform the patients that the latest PIL for Azithromycin Capsules is available on the MHRA website. (https://mhraproducts4853.blob.core.windows.net/docs/f4fbb641c2af3d149295bdea155138b03c7cf56c)

Healthcare professionals and patients may notice that information relating to other medicines have been removed from the latest PIL, due to routine periodic updates and new safety information in line with the reference product information. Please contact xxx@xxx.xx (mailto:xxx@xxx.xx) for more information.

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. (https://mhraproducts4853.blob.core.windows.net/docs/f4fbb641c2af3d149295bdea155138b03c7cf56c)

There is some missing information which is presented below:

What you need to know before you take Azithromycin

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 autoimmune diseases 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. (https://yellowcard.mhra.gov.uk/)

Additional information:

For medical information enquiries please email xxx@xxx.xx (mailto:xxx@xxx.xx) or telephone xx-xxxx-xxxx

For stock control enquiries please email xxx@xxx.xx (mailto:xxx@xxx.xx), or telephone xx-xxxx-xxxx

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Defective Medicines Report Centre10 South ColonnadeCanary WharfLondonE14 4PU

Telephone xx-xxxx-xxxx

xxx@xxx.xx (mailto:xxx@xxx.xx)

Download document

UPDATE: Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11 (https://assets.publishing.service.gov.uk/media/67d1a57d0f8734b8791a1d9a/EL25A11_Jubilant_Azithromycin_PIL_C4_notification_UPDATED.pdf)