Company led medicines recall: Mawdsley-Brooks & Company Limited, Fluphenazin-neuraxpharm® D 25 & 100 mg/ml Solution for Injection, CLMR(23)A/01
Specific batches of the product are recalled as a precautionary measure due to validation tests demonstrating the leaching of filter additives that are above the acceptable limit.
CLMR Number
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]
| 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
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.
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