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.
Betahistine dihydrochloride 8mg Tablets PL 30464/0019
Betahistine 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|
|Betahistine dihydrochloride 16mg Tablets||GY11119||01/10/2022||84||21/04/2020|
Healthcare professionals have been advised to immediately stop supplying the batches and quarantine and return all the stock to their supplier using approved process.