Class 2 Medicines Recall: Betahistine dihydrochloride 8mg and 16mg tablets (Kent Pharmaceuticals Ltd)

Class 2 Medicines Recall: Betahistine dihydrochloride 8mg and 16mg tablets (Kent Pharmaceuticals Ltd)

November 26, 2020

Class 2 MHRA medicines recall – Betahistine dihydrochloride 8mg Tablets (Kent Pharmaceuticals Ltd) PL 30464/0019
Betahistine dihydrochloride 16mg Tablets (Kent Pharmaceuticals Ltd) PL 30464/0020

Drug alert number: EL (20)A/55

Date issued: 26 November 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Betahistine dihydrochloride 8mg Tablets (Kent Pharmaceuticals Ltd) PL 30464/0019
Betahistine dihydrochloride 16mg Tablets (Kent Pharmaceuticals Ltd) PL 30464/0020

Kent Pharmaceuticals Ltd has informed MHRA that the affected batches above are contaminated with theophylline due to a cross-contamination issue identified with an excipient that was used in the manufacture of the finished product. Therefore, a decision has been taken to recall the affected batches.

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

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

Full drug alert can be viewed here.

Company contacts for further information

For stock control enquiries please contact customer.service@kent-athlone.com

For more information or medical information medical@kent-athlone.com



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