CAUTION IN USE – This is not a recall
Jubilant Pharmaceuticals NV has issued a Class 4 Medicines Defect Information – Caution in Use. In relation to:
Various Batches of Azithromycin 250 mg Capsules PL 19156/0138 (4 Cap/pack) & (6 Cap/pack)
Brief description of the 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the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in the table above include an outdated PIL.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 revised in October 2021. The latest approved PIL is dated February 2025.
The out-of-date PIL, revised in October 2021, is missing important updated safety information.
The following details the affected products & batches that have been stocked, sold by NVS
| NVS Product Code(s) | Product Description | Affected Batch No’s | Expiry Date | Stock Position |
|---|---|---|---|---|
| 580648 | AZITHROMYCIN CAPS 250MG – PK 6 | ZQ122006A | Sept-25 | Sold Through |
| ZQ122007A | Sept-25 | Sold Through | ||
| ZQ122008A | Sept-25 | Sold Through | ||
| ZQ123004A | Sept-26 | Sold Through | ||
| ZQ124005A | Jul-27 | Sold Through |
Advice for healthcare professionals
There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL.
What do I need to do next?
Please read the attached notification letter (Please click here) and bring the issue to the attention of all relevant colleagues within your business. The updated PIL is available electronically and can be downloaded from the links within the notification letter:
