Class 4 Medicines Notification, Accord Healthcare Limited, UK, Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion, EL (23)A/30
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 385257, email- 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
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