Alert

Company led medicines recall: Bucain Hyperbar 5mg/ml Solution for Injection (unlicensed medicine), CLMR (22)A/01

Mawdsley-Brooks & Company Limited (UK importer) is recalling a specific batch of this product as a precautionary measure due out of specification result for pH that was identified during routine stability testing.

MDR number: MDR 017-02/22

Company name: Mawdsley-Brooks & Company Limited

Product description: Bucain Hyperbar 5mg/ml Solution for Injection (unlicensed medicine)

Details of the affected batch:

Batch Number

Expiry Date

Pack Size

First Distributed

80516A-1

30/04/2022

5 x 4ml

26/07/2019

Brief description of the problem:

Mawdsley-Brooks & Company Limited (UK importer) is recalling the above batch as a precautionary measure due out of specification result for pH that was identified during routine stability testing.

This product is supplied to hospital pharmacies only.

This recall is being issued as a company-led recall due to the limited number of packs distributed, and the UK importer has full traceability of the product’s onward distribution.

Remaining stock of the above batch should be quarantined and returned to the UK importer directly.

Further Information:

For more information please contact

Charlotte Ray: charlotte.ray@mawdsleys.co.uk.  Tel: 07342 949 102