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].
