Class 3 Medicines Recall: Emylif 50mg orodispersible film, Zambon SpA, EL(25)A/47
Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.
DMRC Number: DMRC - 35367036
Company name:Zambon SpA
Product description: Emylif 50mg orodispersible film - PL: 31654/0013, SNOMED code: 42121311000001106, GTIN: 8031609001824
Details of the affected batch:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| C24QA104 | 04-2027 | 56 sachets | 13/05/2025 |
Background information:
Ongoing stability testing identified out of specification results for unknown impurities at the 24-month stability timepoint for one batch of Emylif films. Emylif films were previously licensed with a 36-month shelf life.
The batch of Emylif 50mg orodispersible film specified in the table is being recalled as a precautionary measure before it reaches 24 months since the date of manufacture (C24QA104 would reach the 24-month timepoint on 30 April 2026).
Out of an abundance of caution, subsequent batches of Emylif 50mg orodispersible film, are labelled with an 18-month shelf life.
This recall is at pharmacy and wholesaler level.
Advice to Healthcare Professionals:
Stop supplying the specified batch immediately. Quarantine all stock from this batch and return it to your supplier using your supplier’s approved process. The batch is being recalled at pharmacy and wholesaler level early as a precautionary measure. Other batches are not affected and may be supplied as per the printed expiry date.
Advice to Patients:
No further action is required by patients as this is a pharmacy and wholesaler level recall. Patients should continue to take medicines from batch C24QA104 as prescribed by the healthcare professional. This batch will remain within specification limits until 30 April 2026.
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 all medical information enquiries and information on this product, please email infoUK@zambongroup.com, or telephone + 44 (0)800 0288 942.
For stock control enquiries please email infoUK@zambongroup.com, or telephone + 44 (0)800 0288 942.
To access the full recall/alert: Class 3 Medicines Recall: Zambon SpA, Emylif 50mg orodispersible film, EL(25)A/47