Kent Pharmaceuticals Ltd has informed the relevant authorities that several batches of finished product were contaminated with theophylline due to a cross-contamination issue identified with an excipient that was used in the manufacture of the finished product.
PL Numbers
PL 30464/0019, PL 30464/0020
MDR Number
MDR 133-11/20
Company Name
Kent Pharmaceuticals Ltd
Product description
Betahistine dihydrochloride 8mg Tablets:
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| EC10619 | 1 October 2022 | 84 | 21 October 2020 |
| EC10719 | 1 October 2022 | 84 | 9 September 2020 |
| EC10819 | 1 October 2022 | 84 | 4 May 2020 |
Betahistine dihydrochloride 16mg Tablets:
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| GY11119 | 01 October 2022 | 84 | 21 April 2020 |
| GY11219 | 01 October 2022 | 84 | 05 May 2020 |
| GY11319 | 01 October 2022 | 84 | 23 September 2020 |
Active pharmaceutical ingredient: betahistine dihydrochloride
Brief description of the problem
Kent Pharmaceuticals Ltd has informed us 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.
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.
Advice for patients
The risk of adverse reactions is low with respect to the level of contamination. However, if patients experience any side effects related to hypersensitivity or those not normally experienced with betahistine, please ensure appropriate clinical advice is sought from your healthcare team. Any suspected side effects should also be reported via the Yellow Card scheme.
Further Information
For stock control enquiries please contact [email protected]
For more information or medical information [email protected]
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
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