Class 3 Medicines Recall: Accord Healthcare Limited, Irinotecan Hydrochloride Concentrate for Solution for Infusion 20mg/ml (5ml vial), EL (20)A/33
Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta). No complaints or adverse reaction reports have been received by the company to date for the UK product.
Product information
PL Number
PL 20075/0443
MDR Number
MDR 074-07/20
Company name
Accord Healthcare Limited
Product description
Irinotecan Hydrochloride Concentrate for Solution for Infusion 20mg/ml (5ml vial)
- Batch Number: X21343
- Expiry Date: 10/2021
- Pack Size: 1 x 5ml vial
- First Distributed: 11/03/2019
Active Pharmaceutical Ingredient: irinotecan hydrochloride
Brief description of the problem
Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta). No complaints or adverse reaction reports have been received by the company to date for the UK product.
Advice for healthcare professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and return these to your supplier using your supplier’s approved process.
Further Information
For more information or medical information queries, please contact:
Medinfo-BST
Tel: 01271 385257
E-mail: medinfo@accord-healthcare.com
For stock control queries, please contact:
Accord-UK Ltd Customer Services Team
Tel: 0800 373573
E-mail: customerservices@accord-healthcare.com
Fax: 01271 346106
Recipients of this Drug Alert 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.
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