Class 4 medicines defect information: Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU PL 16508/0046

By 19th June 2018 News, UK Pharma No Comments

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)

Product information

MDR number

MDR 147-09/17

Company name

Kyowa Kirin

Product description

Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU (Bleomycin sulfate)

PL number

PL 16508/0046

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