Join the DDA or

Mawsdley-Brooks fluphenazin-neuraxpharm D soln recall

Validation test concerns

January 13th 2023

Tagged: MHRA alert

By MHRA

Mawdsley-Brooks is recalling two batches of fluphenazin-neuraxpharm D solution [unlicensed medicine] due to validation test failures.

The two affected batches are:

100 mg/ml Solution for Injection

Batch NumberExpiry DatePack SizeFirst Distributed
20068601/20245 x 1ml21/05/2021

 25 mg/ml Solution for Injection

Batch NumberExpiry DatePack SizeFirst Distributed
20205201/20245 x 1ml16/07/2021

The precautionary measure relates to validation tests demonstrating the leaching of filter additives that are above the acceptable limit.

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

For medical information enquiries, please contact Michelle Biggs at [email protected]

For stock information enquiries, please contact Andrea Dunlop at [email protected]