Class 4 Medicines Defect Information: Aripiprazole 1mg/ml Oral Solution, PL 04569/1667, (EL(20)A/15)
Mylan UK Healthcare Ltd has informed us that a product complaint has been received relating to crystalline precipitate being observed during bottle use. Due to concerns with continuity of supply these batches are not being recalled at this time.
MDR Number
MDR 040-08/19
Company Name
Mylan UK Healthcare Ltd
Product description
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 |
Brief description of the problem
Mylan UK Healthcare Ltd has informed us that a product complaint has been received relating to crystalline precipitate being observed during bottle use. Due to concerns with continuity of supply these batches are not being recalled at this time.
Advice for healthcare professionals
As a precaution it is advised that the product is visually inspected prior to administration and only use if the product is clear and free from crystalline precipitate.
Further information
Please bring this notice to the attention of all relevant staff within your facility. If you have supplied units from the above batches to any other pharmacy or clinic, please forward a copy of this Alert to them.
If you do receive any units with the stated issue, please contact UK complaints via email UKComplaints@mylan.co.uk
For more information or medical information enquiries please contact Mylan UK Healthcare Ltd. Medical Information Department on +44(0) 1707 853000 or via email on Info.uk@mylan.co.uk
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
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