Class 4 Medicines Notification, Accord Healthcare Limited, UK, Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion, EL (23)A/30

Source: MHRA /Gov.uk 23.8.23

Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these products mentioned in this notification.

MDR number

MDR 105-08/23

Company name

Accord Healthcare Limited, UK

Product name

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion

SNOMED Code

2ml- 35849311000001101

Batch No Expiry Date Pack Size First Distributed
M2212320 06/2025 2ML 21-04-2023
M2212979 08/2025 2ML 18-01-2023

Active Pharmaceutical Ingredient: Irinotecan Hydrochloride

Product name

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion

SNOMED Code

5ml- 35849511000001107

Batch No Expiry Date Pack Size First Distributed
M2212561 07/2025 5ML 28-11-2022
M2216090 10/2025 5ML 18-04-2023

Active Pharmaceutical Ingredient: Irinotecan Hydrochloride

Product name

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion

SNOMED Code

15ml- 35849711000001102

Batch No Expiry Date Pack Size First Distributed
G2300725 11/2025 15ML 08-06-2023

Active Pharmaceutical Ingredient: Irinotecan Hydrochloride

Product name

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion

SNOMED Code

25ml- 20275211000001106

Batch No Expiry Date Pack Size First Distributed
M2210458 02/2025 25ML 30-11-2022
M2211881 07/2025 25ML 06-01-2023
G2300727 09/2025 25ML 16-06-2023
M2301081 11/2025 25ML 02-06-2023

Active Pharmaceutical Ingredient: Irinotecan Hydrochloride

Product name

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion

SNOMED Code

50ML-N/A

Batch No Expiry Date Pack Size First Distributed
G2202180 05/2024 50ML 18-01-2023
G2300728 05/2024 50ML 10-07-2023
M2211019 07/2025 50ML 13-10-2022

Active Pharmaceutical Ingredient: Irinotecan Hydrochloride

Brief description of the problem

Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the above batches of these products. The PIL does not include the most up to date safety information regarding the contraindication for Gilbert’s syndrome. The full information missing from the PILs is reproduced below.

Missing Information in PIL:

“Section 2. What you need to know before you are given Irinotecan Injection

Warnings and precautions:
Talk to your doctor, pharmacist or nurse before using Irinotecan Hydrochloride if you have Gilbert’s syndrome, an inherited condition that can cause elevated bilirubin levels and jaundice (yellow skin and eyes).”

Advice for healthcare professionals

There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the product and where possible, provide an updated PIL. The updated PIL is available electronically and can be downloaded from the Accord website.

Healthcare professionals are advised to exercise caution when prescribing this product to UGT1A1 poor metabolisers, such as patients with Gilbert’s syndrome, due to an increased risk of severe adverse reactions. Consult the Summary of Product Characteristics for further advice.

Advice for patients

This issue is about missing information on the Patient Information Leaflets (PILs). The medicine itself is not affected and therefore patients do not need to take any action. Talk to your doctor, pharmacist or nurse before using Irinotecan Hydrochloride if you have Gilbert’s syndrome, an inherited condition that can cause elevated bilirubin levels and jaundice (yellow skin and eyes). Your cancer team can provide more information.

These products will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care. If you have any concerns, please speak with your cancer team or your healthcare professional in the first instance.

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.

Further Information

For medical information enquiries please contact:

Accord Medical Information Department on 01271 385257email- medinfo@accord-healthcare.com

For stock control enquiries please contact:

Accord- Customer Services Team on 0800 373573

Recipients of this Medicines Recall 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

DMRC@mhra.gov.uk

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Class 4 Medicines Notification, Accord Healthcare Limited, UK, Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion, EL (23)A/30

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