Kent Pharmaceuticals Ltd has informed us that several 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. Therefore a decision has been taken to recall the affected batches.
Advice for healthcare professionals:
Stop supplying the listed 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. Any suspected side effects should also be reported via the
Yellow Card Scheme
Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website
https://www.gov.uk/drug-device-alerts