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:

*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: 

Class 3 Medicines Recall: Kimmtrak 200 micrograms/mL concentrate for solution for infusion, Immunocore Limited, EL(25)A/28