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ALERT: Dispensers advised to check Aripiprazole bottles for crystalline precipitate

Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Medicines Defect Information for Aripiprazole 1mg/ml Oral Solution by Mylan.

The regulator said Mylan UK has received a product complaint relating to crystalline precipitate being observed during bottle use.


The affected bathes are not being recalled to ensure continuity of supply of the anti-psychotic medicine, MHRA added.

Healthcare professionals are advised to visually inspect the product prior to administration and only use if the product is clear and free from crystalline precipitate.

The affected batches are:

Product: Aripiprazole 1mg/ml Oral Solution PL 04569/1667

Batch numberExpiry datePack sizeFirst distributed
05051930 April 2021150ml01 October 2019
04081931 July 2021150ml03 February 2020
07021931 January 2021150ml07 August 2019

Mylan can be contacted by emailing UKComplaints@mylan.co.uk if anyone receives units with the issue.

For more information or medical information enquiries, contact Mylan UK’s medical information department on +44(0) 1707 853000 or via email on Info.uk@mylan.co.uk.