Class 3 Medicines Recall: Kimmtrak 200 micrograms/mL concentrate for solution for infusion, Immunocore Limited, EL(25)A/28
Immunocore Limited is recalling the batches listed below as a precautionary measure. The recall is due to a decrease in potency identified during stability testing. All other stability test results remain within specification.
DMRC Number:DMRC-35860567
Company name: Immunocore Limited
Product description:
Kimmtrak 200 micrograms/mL concentrate for solution for infusion
PLGB: 36781/0001
Active ingredient: tebentafusp
SNOMED code: 274087000
Details of the affected batch:
Batch No. | Expiry Date | Pack Size | First Distributed |
3D009AA17 | 31/03/2026 | 1 vial | 08/2024 |
3D009AA19 | 31/03/2026 | 1 vial | 10/2024 |
3D009AA36 | 31/03/2026 | 1 vial | 12/2024 |
3D009AA39* | 31/03/2026 | 1 vial | 01/2025 |
3D009AA04* | 31/03/2026 | 1 vial | 09/2024 |
*distributed in Northern Ireland only
Brief description of problem:
Immunocore Limited is recalling the batches listed above as a precautionary measure. The recall is due to a decrease in potency identified during stability testing. All other stability test results remain within specification.
Only the batches listed in the above table are impacted. This does not affect other batches that are available.
Advice to Healthcare Professionals:
Stop supplying the impacted batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process. The batches listed in the table are being recalled as a precautionary measure.
Advice to Patients:
Patients who are taking Kimmtrak 200 micrograms/mL concentrate for solution for infusion (tebentafusp) should continue to take the medication. This is a wholesale and pharmacy level recall that will be actioned by your healthcare professional.
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 medinfo.eu@immunocore.com, or telephone +442076645100 (local toll) or +00 800-74451111 (toll-free).
For stock control enquiries please email john.sandford@immunocore.com, or telephone +00353(0)858515258.
To access the full recall: