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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 30464/0019
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
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.

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