Mylan UK has received a product complaint relating to crystalline precipitate being observed during bottle use of Aripiprazole 1mg/ml Oral Solution. Photo: iStock

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 number Expiry date Pack size First distributed
050519 30 April 2021 150ml 01 October 2019
040819 31 July 2021 150ml 03 February 2020
070219 31 January 2021 150ml 07 August 2019

 

Mylan can be contacted by emailing [email protected] 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 [email protected].

If you want to share your stories and/or experiences with us, please send an email to [email protected]

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