MHRA issues Medicine Defect Information about Aripiprazole
Posted: 12 March 2020 | Hannah Balfour (European Pharmaceutical Review) | No comments yet
The regulatory body has issued guidance based on a complaint that stated a precipitate formed in Aripiprazole 1mg/ml oral solution.
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.
Related topics
Drug Safety, Drug Supply Chain, Formulation, QA/QC, Supply Chain, Therapeutics
