Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)
Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU (Bleomycin sulfate)
|Batch number||Expiry date||Pack size||First distributed|
|Y7B290||Oct 2020||10||Jun 2018|
Brief description of the problem
In April 2017, glass particles were detected in a batch of Bleo-Medac (bleomycin sulfate) from the same manufacturer.
Advice for healthcare professionals
While investigations are ongoing, additional measures should be adopted:
- follow all the recommended steps for the preparation of Bleo-Kyowa in accordance with the Summary of Product Characteristics
- carefully inspect the reconstituted product under a bright light
- if particulate or glass matter is visible after reconstitution, do not administer the product to patients. Please retain the vial, quarantined safely away from other stock and notify the marketing authorisation holder
- if there is no visible particulate matter after reconstitution, the use of a standard 5-micron (5 µm) filter needle to withdraw the reconstituted product from the vial prior to administration is recommended as glass particles may be difficult to see
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.
Company contact information
Kyowa Kirin Medical Information
Tel: +44 (0)1896 664000