Company Led Recall: Mawdsley-Brooks & Company Limited, Fluphenazin-neuraxpharm® D 25 & 100 mg/ml Solution for Injection, CLMR(23)A/01

MDR Number: MDR 234-11/22

Company name: Mawdsley-Brooks & Company Limited

Product description:

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

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

Brief description of problem:

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.

Advice to Pharmacies:

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

Company contacts for further information:

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

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

Access the full recall