The Mylan UK Healthcare Ltd has recalled all remaining stocks of five batches of Ancotil 2.5 g/250 ml solution for infusion as a precautionary measure.
The company’s announcement come after a product sterility non-compliance event which occurred during a recent inspection at the contract manufacturing site, the Medicines and Healthcare products Regulatory Agency (MHRA) said in its update on Thursday (12).
Product details
Ancotil 2.5 g/250 ml Solution for Infusion
PL 46302/0116
MDR 092-09/20
Active Pharmaceutical Ingredient: Flucytosine
| 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 |
The healthcare professionals have been suggested to stop supplying the batches immediately and quarantine all stock and return the same to their supplier using supplier’s approved process.
