Class 4 MHRA drug alert – Bleo-Kyowa, Powder for Solution for Injection, 15,000 IU (Kyowa Kirin)

Class 4 MHRA drug alert – Bleo-Kyowa, Powder for Solution for Injection, 15,000 IU (Kyowa Kirin)

June 19, 2018

Class 4 MHRA drug alert – Bleo-Kyowa, Powder for Solution for Injection, 15,000 IU (Kyowa Kirin)

Drug alert number: EL (18) A/09

Date issued: 19th June 2018

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use for:

Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU PL 16508/0046

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.

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

PL number: PL 16508/0046.

To view the alert please visit the GOV.uk website.



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