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Class 4 Drug Alert (Caution in use) Bleo-Kyowa Powder For Solution For Injection 15,000iu

Class 4 Drug Alert (Caution in use) Bleo-Kyowa Powder For Solution For Injection 15,000iu

Kyowa Kirin continues to investigate the root cause of quality defect in a batch of Bleo-Medac Powder for Solution for Injection, 15,000 IU - reports of glass particles, which 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. To maintain continuity of supply in the UK, the marketing authorisation holder will distribute new batches of Bleo-Kyowa that meet current specifications. However, while investigations continue, the MHRA recommends that healthcare professionals adopt precautionary measures during product reconstitution.

Please visit the: MHRA website for more details on this drug alert.

The affected products' details are as follows:

PIP Code Product Description Supplier Affected Batch
Alliance Do Not Stock Bleo-Kyowa Powder For Solution For Injection 15,000iu Kyowa Kirin 97B210

Alliance Healthcare do not stock and therefore we are not accepting stock returns.

For quality or medical information enquiries, please contact Kyowa Kirin Medical Information on (0)1896 664 000 or email - medinfo@kyowakirin.com.

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

 

If you have any questions, then please contact your local Service Centre Customer Services team.