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 reference number
DMRC-35860567
Marketing Authorisation Holder
Immunocore Limited
Medicine Details
Kimmtrak 200 micrograms/mL concentrate for solution for infusion
PLGB: 36781/0001
Active ingredient: tebentafusp
SNOMED code: 274087000
GTIN: 05056416800029
Affected Lot Batch Numbers
| 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
Background
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 for 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 for 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.
Additional 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.
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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