Class 2 Medicines Recall, Mylan UK Healthcare Ltd, Ancotil 2.5 g/250 ml Solution for Infusion, PL 46302/0116, EL (20) A/53
Mylan UK Healthcare Ltd is recalling remaining stock of certain batches as a precautionary measure after a product sterility non-compliance event which occurred during a recent inspection at the contract manufacturing site.
Product information
PL Number(s)
- Ancotil 2.5 g/250 ml Solution for Infusion, PL 46302/0116
MDR Number
MDR 092-09/20
Company name
Mylan UK Healthcare Ltd
Product description
Ancotil 2.5 g/250 ml Solution for Infusion
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 113987 | 02/2021 | 5 | 26 July 2019 |
| 114626 | 03/2021 | 5 | 18 July 2019 |
| 114711 | 05/2021 | 5 | 22 November 2019 |
| 115051 | 05/2021 | 5 | 05 December 2019 |
| F20CBJ | 11/2021 | 5 | 23 April 2020 |
Active Pharmaceutical Ingredient: flucytosine
Brief description of the problem
Mylan UK Healthcare Ltd has been informed of a non-compliance event which occurred during the most recent inspection at the contract manufacturing site for the above product in relation to product sterility. As a precautionary measure, remaining stock of the above batches are being recalled.
Advice for healthcare professionals
Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.
Further Information
For more information or medical information enquiries please contact Mylan UK Healthcare Ltd Medical Information Department on +44(0) 1707 853000 or via email at [email protected].
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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