Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11 (UPDATED)
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the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in the table include an outdated PIL.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 Number: DMRC-34866680
Company name: Jubilant Pharmaceuticals NV
Product description: Azithromycin 250 mg Capsules Licence: PL 19156/0138, SNOMED code: 1303911000001105 (4 Cap/pack), 1135911000001109 (6 Cap/pack)
Details of the affected batches:
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| ZQ122005A | 09.2025 | 4 Cap/pack | 07/11/2023 |
| ZQ122006A | 09.2025 | 6 Cap/pack | 14/02/2023 |
| ZQ122007A | 09.2025 | 6 Cap/pack | 11/08/2023 |
| ZQ122008A | 09.2025 | 6 Cap/pack | 08/11/2023 |
| ZQ123003B | 09.2025 | 6 Cap/pack | 26/01/2024 |
| ZQ123004A | 09.2025 | 6 Cap/pack | 27/02/2024 |
| ZQ124001A | 12.2026 | 6 Cap/pack | 28/02/2024 |
| ZQ124002A | 12.2026 | 4 Cap/pack | 24/05/2024 |
| ZQ124003A | 12.2026 | 4 Cap/pack | 22/07/2024 |
| ZQ124005A | 07.2026 | 6 Cap/pack | 19/12/2024 |
| ZQ124006A | 07.2027 | 4 Cap/pack | 07/01/2025 |
Brief description of problem:
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the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in the table above include an outdated PIL.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The out of date PIL in the tabled batches is missing important updated safety information, please refer to the table in Appendix 2 and a copy of the full PIL is also available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 to 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 in the packs, please inform the patients that the latest PIL for Azithromycin Capsules is available on the MHRA website.
Advice to 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. 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 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.
Company contacts for further 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
To access the full recall: Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11