The Medicines and Health products Regulatory Agency (MHRA) has issued a drug recall for Betahistine dihydrochloride 8, 16mg tablets of Kent Pharmaceuticals Ltd.
Kent has informed that the following affected batches are contaminated with theophylline due to a cross-contamination issue identified with an excipient that was used in the manufacture of the finished product.
Product details
Betahistine dihydrochloride 8mg Tablets PL 30464/0019Betahistine dihydrochloride 16mg Tablets PL 30464/0020
| Product | Batch Number | Expiry Date | Pack Size | First Distributed | |||
| Betahistine dihydrochloride 8mg Tablets | EC10619 | 01/10/2022 | 84 | 21/10/2020 | |||
| EC10719 | 01/10/2022 | 84 | 09/09/2020 | ||||
| EC10819 | 01/10/2022 | 84 | 04/05/2020 | ||||
| Betahistine dihydrochloride 16mg Tablets | GY11119 | 01/10/2022 | 84 | 21/04/2020 | |||
| GY11219 | 01/10/2022 | 84 | 05/05/2020 | ||||
| GY11319 | 01/10/2022 | 84 | 23/09/2020 | ||||
Healthcare professionals have been advised to immediately stop supplying the batches and quarantine and return all the stock to their supplier using approved process.
