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Class 2 Medicines Recall: Kent Pharmaceuticals Ltd, Betahistine dihydrochloride 8mg and 16mg Tablets, EL (20)A/55

Published On:

26 November 2020

Published In:

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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Class 2 Medicines Recall: Kent Pharmaceuticals Ltd, Betahistine dihydrochloride 8mg and 16mg Tablets, EL (20)A/55

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