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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