Bleo-Kyowa®, Powder for Solution for Injection (Bleomycin sulfate), 15,000 IU
Brief description of the problem
In April 2017, glass particles were detected in a batch of Bleo-Medac (bleomycin sulfate) from the same manufacturer.
Actions for healthcare professionals
In April 2017, reports of glass particles in a batch of Bleo-Medac Powder for Solution for Injection, 15,000 IU, resulted in recall in some European countries. No recall action was necessary in the UK as the affected batch had not been distributed in the UK.
The marketing authorisation holder continues to investigate the root cause of this quality defect. To maintain continuity of supply in the UK, the marketing authorisation holder will distribute new batches of Bleo-Kyowa that meet current specifications.
If you have any questions about this letter or any other enquiry, please contact Kyowa Kirin Medical Information:
Tel: +44 (0)1896 664000
Recipients of this Drug Alert should bring it to the attention of all relevant contacts involved with the supply and administration of chemotherapy, including: hospital pharmacists; hospital clinicians; ward staff; chemotherapy unit staff; nursing staff and clinic staff by copy of this letter.
In addition, the relevant Healthcare Professionals should be informed where the product is being used in a domiciliary setting. Local area teams are asked to forward this to relevant clinics and hospital pharmacy departments.
Published 22 February 2018