Company led medicines recall: Fluphenazin-neuraxpharm® D 25 & 100 mg/ml Solution for Injection Mawdsley-Brooks & Company Limited

CLMR number: CLMR (23)A/01

Date issued: 12th January 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led medicines recall for: Fluphenazin-neuraxpharm® D 25 & 100 mg/ml Solution for Injection (Mawdsley-Brooks & Company Limited).

Fluphenazin-neuraxpharm® D 100 mg/ml Solution for Injection [unlicensed medicine]

Batch number Expiry Date Pack Size First Distributed
200686 01/2024 5 x 1ml 21/05/2021

Active ingredient: Fluphenazine

Fluphenazin-neuraxpharm® D 25 mg/ml Solution for Injection [unlicensed medicine]

Batch number Expiry Date Pack Size First Distributed
202052 01/2024 5 x 1ml 16/07/2021

Active ingredient: Fluphenazine

Specific batches of product are recalled as a precautionary measure due to validation tests demonstrating the leaching of filter additives that are above the acceptable limit.

This recall is being issued as a company-led medicines recall as the products are only supplied to limited number of customers, and the manufacturer has full traceability of the product’s distribution.

Remaining stock of the above batches should be quarantined and returned to Mawdsleys directly.

Company Contact for medical information enquiries

For medical information enquiries, please contact Michelle Biggs at michelle.biggs@mawdsleys.co.uk

Company Contact for stock enquiries

For stock information enquiries, please contact Andrea Dunlop at andrea.dunlop@mawdsleys.co.uk

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

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