Kyowa Kirin Bleo-Kyowa® injection defect information

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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” MHRA (2017).

MHRA report “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.”

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