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MHRA issues Medicine Defect Information about Aripiprazole

The regulatory body has issued guidance based on a complaint that stated a precipitate formed in Aripiprazole 1mg/ml oral solution.

Medicine manufacturing

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has been informed by Mylan UK Healthcare Ltd that they received a complaint about a crystalline precipitate forming in Aripiprazole 1mg/ml oral solution.

According to the MHRA, the product is not being recalled due to concerns with continuity of supply. However, they advise that when Aripiprazole 1mg/ml oral solution is used it is visually inspected prior to administration to ensure it is clear and free of any precipitates.

Aripiprazole oral solution is indicated for the treatment of schizophrenia in adults and adolescents aged over 15 years. The drug is also used in treating moderate to severe manic episodes in Bipolar I Disorder patients aged 13 and older.

The affected lots are:

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

More information on the alert can be found here

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