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)

November 14, 2017

Drug alert number: EL (17) A/11

Date issued: 13th November 2017

The Medicines and Healthcare products Regulatory agency (MHRA) has issued a class 4 caution in use, for:

Bleo-Kyowa, powder for solution for injection, 15,000 IU, 1 x 10 (Kyowa Kirin)

PL number: 16508/0046

Batch number: 97B210

Expiry date: 31st August 2020

In April 2017, glass particles were detected in a batch of Bleo-Medac (bleomycin sulfate) from the same manufacturer. To maintain continuity of supply in the UK, the marketing authorisation holder will distribute new batches of Bleo-Kyowa that meet current specifications.

While investigations continue, the MHRA recommends that healthcare professionals adopt additional measures, which can be viewed on the GOV.uk website.

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



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